Clincosm LogoSign in Get a demo

SIbackpain: Correction of Low Back Pain From Sacroiliac Malrotation With a Simple in Home Exercise

Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT03888235
Collaborator
(none)
62
Enrollment
1
Location
3
Arms
9.5
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

60 participants with low back pain will be examined to determine the direction and extent of sacroiliac malrotation. If malrotation exists, they will be randomized to 3 treatment groups: 1 will be taught how to use their thigh to push the anterior superior iliac spine (ASIS) backwards for an anterior malrotation and their sartorius and rectus femoris to pull their ASIS and anterior inferior iliac spine (AIIS) forward for a posterior malrotation. 2: will be given a pelvic stabilization belt. 3: will return in one month. At the second visit at one month all participants will be treated with both exercise and belt. They will be reassessed at the third visit one month later: the scores for immediate and delayed treatment groups will be compared. Their response to these exercises and/or the pelvic belt will be tested at the first second and third visits, using the brief pain inventory pain, the Oswestry disability scores and the distance between the (posterior superior iliac spine) (PSIS) levels, filled out at every contact. Their satisfaction with previous treatments used will be compared to their satisfaction when using the exercise and belt.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immediate corrective exercises
  • Device: Immediate use of pelvic support belt
  • Other: Delayed treatment
 N/A

Detailed Description

Potential participants with low back pain will answer a questionnaire to eliminate lumbar or hip pathology, ankylosing spondylitis or major leg length discrepancy as cause. If they state they do not have these, they will be given an appointment to be assessed to eliminate the presence of these conditions and to determine if they suffer from sacroiliac malrotation. To this effect, the sacroiliac forward flexion test (SIFFT) will be done: leaning on a counter with their body horizontal to tilt the pelvis forward and lower the sacrum and their legs vertical to push the innominate bones upwards via the hip joints, to expose the posterior superior iliac spines (PSISs). Pressure below the PSISs will be used to assess their inferior limits which will be marked and their levels assessed using a carpenter's level. The distance between the PSIS levels will be recorded. If there is tenderness under the higher PSIS, the ilium is malrotated anteriorly on the sacrum. If the area under the lower PSIS is tender, the ilium is malrotated posteriorly on the sacrum.

Participants are then randomized into three groups: group 1 is taught how to assess the direction of the malrotation, then how to perform the appropriate corrective exercise:

  • With the foot of the anteriorly rotated side and the knee on the posteriorly rotated side on the floor, hands on the floor on either side of the foot, the participant leans forward hard to push his anteriorly rotated ilium posteriorly with his thigh and stretches the opposite thigh posteriorly to pull the posteriorly rotated ilium forward.

  • Anterior malrotation can also be corrected by placing the foot on the malrotated side on a chair seat, flexing the other knee to touch the seat edge and pulling with both hands up on the seat while leaning back, to drive the thigh against the anterior superior iliac spine (ASIS), thus pushing it backwards.

  • If unable to do these, participants can lie supine on the table, thigh on the posterior side extended. On the anterior side the knee is flexed and the foot is on the assistant's sternum as he/she leans forward, pushing the thigh against the ASIS. Downward pressure on the sartorius and rectus femoris just above the knee causes the ASIS and the anterior inferior iliac spine (AIIS) to be pulled on, rotating the ilium anteriorly.

Each position is held for 2 minutes, with up to 2 repetitions as needed. At home, the procedure is repeated as needed for pain relief.

Group 2 are given a pelvic stabilization belt and taught how to apply it: tightly around the pelvis below the anterior superior iliac spines (ASISs), to stabilize the sacroiliac joints as malrotation occurs as a result of pelvic instability. The belt is used for activities known to cause back pain.

Group 3 are instructed to continue their usual treatments and given an appointment to return one month later to receive instruction for the exercise and given the belt At 1 month all are reassessed. Group 1: use and effectiveness of the exercises is recorded and they are given the belt. Group 2: use and effectiveness of the belt is recorded and they are taught how to examine and correct their sacroiliac joints. Group 3: use and satisfaction with their current treatment is recorded. They are then taught the examination and corresponding exercise and given the belt.

At 2 months, when all participants have used both treatments for one month, all are reassessed.

Data collected includes:

at the first visit: Diagnoses associated with low back pain: lumbar spondylosis, hip arthritis, hypermobility, leg length discrepancy.

Conditions associated with sacroiliac malrotation, tendinitis of sacroiliac joint stabilizer muscles and lateral femoral cutaneous neuropathy. Muscle insertions tested include quadratus lumborum, gluteus medius and minimus, piriformis, iliopsoas, biceps femoris, semimembranosus and semitendinosus.

At all visits:

Brief pain inventory pain severity (BPI PS), the Oswestry low-back disability scores (ODI) and the distance in centimetres between the posterior superior iliac spine levels from the

SIFFT test (PSISL), at intake, one month and two months visits. Together with the following:

Use of pain medications alcohol and marijuana Use and satisfaction with other treatments for back pain relief (physiotherapy, acupuncture, yoga, core exercises, chiropractor, massage).

Position of the malrotated sacroiliac joint or joints. Distance in centimetres between the levels of the PSISs before and after the corrective exercise. (Visits 2 and 3 for all, visits 1, 2, 3 for group 1) Numeric rating scale pain score after the corrective exercise. Use of and satisfaction with the SI corrective exercise at first visit for group 1 and at the second and third visit for all.

Use of and satisfaction with the pelvic belt at the first visit for group 2 and at the second and third visits for all.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Of all the patients with low back pain, those with sacroiliac malrotation will be randomized to: group 1 an exercise to correct the malrotation, group 2 given a pelvic belt to stabilize the sacroiliac joints, group 3: use of usual treatment and treatment with the belt and exercise one month later. The degree of pain relief and improved function between the first visit and the second visit one month later will be assessed.Of all the patients with low back pain, those with sacroiliac malrotation will be randomized to: group 1 an exercise to correct the malrotation, group 2 given a pelvic belt to stabilize the sacroiliac joints, group 3: use of usual treatment and treatment with the belt and exercise one month later. The degree of pain relief and improved function between the first visit and the second visit one month later will be assessed.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Frequency of Sacroiliac Malrotation in Low Back Pain and Correction With a Simple In-home Exercise: A Randomized Study Comparing Those Treated Immediately to Those Waiting One Month for Treatment
Actual Study Start Date :
Nov 28, 2019
Actual Primary Completion Date :
Sep 11, 2020
Actual Study Completion Date :
Sep 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate corrective exercises

At this visit, participants will be examined as described in the protocol and given an exercise to correct their sacroiliac malrotation. They will use this exercise as needed for pain control. They will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that.

Procedure: Immediate corrective exercises
The sacroiliac forward flexion test (SIFFT) finds the position of each innominate bone. Subjects learn 1 of 3 exercises. To correct anterior rotation, flex the thigh hard against the ilium, pushing it backwards. To correct posterior rotation, hyperextend the thigh to pull the ilium forward. 1.Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. 2. Supine, anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. 3. For anterior rotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold position for 2 minutes. Use as needed for pain control. They are reassessed one month later when they receive the pelvic support belt. Both treatments used together will be assessed one month after.
Other Names:
  • Immediate use of sacroiliac corrective exercises

    		•
    Experimental: Immediate use of pelvic support belt

    Participants will be given a pelvic support belt to stabilize their pelvis. They will use this belt for activities likely to precipitate back pain. They will be reassessed one month later. At that time they will be given the exercises and the concurrent use of both treatments will be assessed at their last visit one month after that.

    Device: Immediate use of pelvic support belt
    Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later.
    Other Names:
  • Serola pelvic support belt

    		•
    Active Comparator: Delayed treatment

    These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt. The concurrent use of both treatments will be assessed at their last visit one month after that.

    Other: Delayed treatment
    Participants will continue the treatments they are currently using to relieve their low back pain for one month. At their one-month visit, they will be taught how to assess the direction of sacroiliac malrotation and how to do the corrective exercise. They will also be fitted for a pelvic stabilization belt.
    Other Names:
  • One month delay prior to receiving sacroiliac corrective exercises and pelvic support belt

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care [From baseline to 1 month after each participant used their assigned treatment]

      Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 1 month later. This score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored X5). Minimum = 0, maximum = 100. Higher scores mean a worse outcome.

    2. Oswestry Low-Back Pain Disability Questionnaire Score Change Baseline Minus 2 Month Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt [Two months: from baseline visit to last visit two months later when all participants have used both the pelvic stabilization belt and the corrective exercise for one month]

      Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 2 months later after using the corrective exercise + the pelvic stabilization belt for one month. =(ODI at assessment - ODI at 2 months). The ODI score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored). Minimum = 0, maximum = 100. Higher scores mean greater disability, a worse outcome. The greater the change, the better the outcome.

    Secondary Outcome Measures

    1. Brief Pain Inventory Score Change Over One Month. Baseline Score Minus 1 Month Score. Comparison: Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care [1 month after initial visit (baseline BPI pain score minus one-month BPI pain score) with each group using their assigned treatment]

      Change in BPI pain score between baseline assessment visit and visit one month later: on a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours: • on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the one month visit means a better outcome.

    2. Brief Pain Inventory (BPI) Pain Score Change Over Two Months Comparison: Baseline (BPI) Pain Score Minus 2 Month (BPI) Pain Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt [2 months after baseline visit when all groups have used both the pelvic stabilization belt and the corrective exercise for one month]

      Change in BPI pain score between baseline visit and visit minus BPI pain score two months later after one month of using corrective exercise + pelvic stabilization belt On a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours: • on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the later visit means a better outcome.

    3. Distance Between The Posterior Superior Iliac Spine Levels (PSISL) Using The Sacroiliac Forward Flexion (SIFFT) Test Comparing Corrective Exercise, Pelvic Belt, Conventional Treatment: Baseline Value Minus 1 Month Value.. [One month comparing the different treatments at baseline and one month later.]

      Difference in distance in centimetres between the levels of the higher & the lower posterior superior iliac spines as measured using a carpenter's level between the value found on admission and that found one month later (PSISL). The minimum is 0 cm, the maximum is 3.5 cm. Higher scores mean a worse outcome. The greater difference when the distance is calculated between admission and one or two months later means a better outcome.

    4. Distance Between The Posterior Superior Iliac Spine Levels (PSISL) Using The Sacroiliac Forward Flexion (SIFFT) Test, Baseline Minus One Month After Using Corrective Exercise (SIFFTE) + Pelvic Stabilization Belt. [2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month.]

      The distance between the levels (determined using a carpenter's level) of the higher & the lower posterior superior iliac spines (PSISL) was measured in centimetres. The outcome measure is the difference between the value found on admission and that (PSISL) value found two months later after all participants have use the corrective exercises (SIFFT E) and the sacroiliac stabilizer belt for one month. The minimum is 0 cm, the maximum is 3.5 cm. On admission, higher scores mean a worse outcome. The greater difference when the distance is calculated between admission and two months later means a better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age 19 to 90

    • Participants present with pain in their low back (below the waist) or their buttocks.

    • Able to attend all 3 study visits at the participating physician's office.

    • Able to attend at least the first two visits with someone willing to assist them in assessing their back and help them with the necessary exercise if need be.

    • Willing to perform the corrective exercise and or wear the sacroiliac stabilization belt at home as needed

    • Their posterior superior iliac spines (PSISs) are not level on initial examination.

    • The long dorsal sacroiliac ligament below at least one of the (PSISs) is tender to palpation on initial examination.

    Exclusion Criteria:

    • Pain experienced is lumbar in origin

    • Pain secondary to hip or other pathology

    • PSISs are level at initial examination

    • No tenderness to pressure under the PSISs

    • Severe pain elsewhere in the body, making the assessment of back pain difficult.

    • Presence of ankylosing spondylitis (seen on x-ray, pain worse at night, relieved by exercise, abnormal C reactive protein (CRP) or erythrocyte sedimentation rate (ESR)

    • Obvious leg length discrepancy (> 1 ½ cm) when measured umbilicus to medial malleolus.

    • Location of PSISs cannot be assessed accurately due to back mice or obesity.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Helene Bertrand Inc. North Vancouver British Columbia Canada V7M 2K2

    Sponsors and Collaborators

    • University of British Columbia

    Investigators

    • Principal Investigator: Helene Bertrand, University of British Columbia Department of family practice

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Helene Bertrand, Principal Investigator, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT03888235
    Other Study ID Numbers:
    • H19-01224
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Helene Bertrand, Principal Investigator, University of British Columbia
    Sacroiliac Instability
    Sacroiliac Strain
    Hypermobility
    sacroiliac sprain
    tendinopathy
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain

    Study Results

    Participant Flow

    Recruitment Details Back pain sufferers on a first visit at the doctor's office
    Pre-assignment Detail Included were those with evidence of sacroiliac malrotation, excluded were those suffering from sciatic neuropathy, ankylosing spondylitis, hip pathology and leg length discrepancy greater than 3 cm.
    Arm/Group Title Immediate Corrective Exercises Immediate Use of Pelvic Support Belt Delayed Treatment
    Arm/Group Description After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are: Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later. These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt. The concurrent use of both treatments will be assessed at their last visit one month after that. Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention.
    Period Title: Overall Study
    STARTED 21 21 20
    COMPLETED 20 20 20
    NOT COMPLETED 1 1 0

    Baseline Characteristics

    Arm/Group Title Immediate Corrective Exercises Immediate Use of Pelvic Support Belt Delayed Treatment Total
    Arm/Group Description After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are: Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later. These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be assessed then given both the exercise and the pelvic stabilization belt to use for one month. The concurrent use of both treatments will be assessed at their last visit two months after their initial visit. Total of all reporting groups
    Overall Participants 21 21 20 62
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    16
    76.2%
    19
    90.5%
    16
    80%
    51
    82.3%
    >=65 years
    5
    23.8%
    2
    9.5%
    4
    20%
    11
    17.7%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    50.14
    (15.05)
    51.8
    (10.97)
    54.3
    (12.94)
    52.03
    (13)
    Sex: Female, Male (Count of Participants)
    Female
    15
    71.4%
    14
    66.7%
    10
    50%
    39
    62.9%
    Male
    6
    28.6%
    7
    33.3%
    10
    50%
    23
    37.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    4.8%
    0
    0%
    0
    0%
    1
    1.6%
    White
    18
    85.7%
    14
    66.7%
    19
    95%
    51
    82.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    2
    9.5%
    7
    33.3%
    1
    5%
    10
    16.1%
    Region of Enrollment (participants) [Number]
    Canada
    21
    100%
    21
    100%
    20
    100%
    62
    100%
    Sacroiliac Forward Flexion Test (SIFFT) (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    1.514
    (0.688)
    1.286
    (0.741)
    1.281
    (0.594)
    1.359
    (0.676)

    Outcome Measures

    1. Primary Outcome
    Title Oswestry Low-back Pain Disability Questionnaire Score Change Baseline Minus 1 Month: Comparison Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care
    Description Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 1 month later. This score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored X5). Minimum = 0, maximum = 100. Higher scores mean a worse outcome.
    Time Frame From baseline to 1 month after each participant used their assigned treatment

    Outcome Measure Data

    Analysis Population Description
    Participants entering the study all suffered from low back pain from sacroiliac malrotation.
    Arm/Group Title Immediate Corrective Exercises (SIFFTE) Immediate Use of Pelvic Support Belt Delayed Treatment
    Arm/Group Description After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises (SIFFTE) to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are: Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation (SIFFTE) and the concurrent use of both treatments will be assessed at their last visit one month later. These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the corrective exercise (SIFFTE) and the pelvic support belt. The concurrent use of both treatments, the corrective exercise (SIFFTE) and the pelvic support belt will be assessed at their last visit one month after that.
    Measure Participants 21 21 20
    Median (Inter-Quartile Range) [score on a scale]
    8
    2
    -2.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt, Delayed Treatment
    Comments The null hypothesis assumes that after one month, there is no difference in Oswestry low back pain and disability score improvement between the three treatment groups.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method Kruskal-Wallis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Delayed Treatment
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments SI Exercise versus usual care. Bonferroni alpha correction p< 0.0167
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Immediate Use of Pelvic Support Belt, Delayed Treatment
    Comments Null hypothesis: there is no difference in Oswestry low back pain and disability score between those using a pelvic support belt and those using usual treatment
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.314
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    2. Primary Outcome
    Title Oswestry Low-Back Pain Disability Questionnaire Score Change Baseline Minus 2 Month Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt
    Description Change in Oswestry low-back disability questionnaire (ODI) score between assessment visit and visit 2 months later after using the corrective exercise + the pelvic stabilization belt for one month. =(ODI at assessment - ODI at 2 months). The ODI score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored). Minimum = 0, maximum = 100. Higher scores mean greater disability, a worse outcome. The greater the change, the better the outcome.
    Time Frame Two months: from baseline visit to last visit two months later when all participants have used both the pelvic stabilization belt and the corrective exercise for one month

    Outcome Measure Data

    Analysis Population Description
    All participants, Oswestry low-back pain disability questionnaire score change: baseline minus the score two months later after one month of use of corrective exercises and sacroiliac stabilization belt.
    Arm/Group Title Baseline Oswestry Disability Index (ODI) Score ODI After Immediate Corrective Exercises + Sacroiliac Stabilization Belt Used For One Month
    Arm/Group Description All participants received the Oswestry Disability Index ODI questionnaire on being admitted in the study. The ODI score is calculated from the sum of the scores in each of 10 sections. Each section is rated 0 for no problem to 5 for complete disability. Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored X5). Minimum = 0, maximum = 100. Higher scores mean a worse outcome. All participants get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine (PSIS) levels are found and measured. A higher painful PSIS has anterior, a lower one has posterior malrotation. They are given the appropriate exercise to correct their sacroiliac malrotation. Anterior rotation is corrected with the flexed thigh pushing hard on the anterior superior iliac spine to force it posteriorly. Posterior rotation is corrected by hyperextending the thigh, using the sartorius and the rectus femoris to pull the ilium anteriorly. 3 techniques: - genuflection, anterior side foot and posterior side knee on the floor, hands on either side of the foot, knee stretched backwards, - anterior side foot on chair, pull up on chair to force the thigh against the ilium, - in dorsal decubitus assistant with anterior side foot on their sternum leans forward to push the thigh against ilium and pushes down on extended posterior side thigh to overstretch it. All these are held for 2 minutes. They are then fitted with a sacroiliac stabilization belt to wear as needed for back pain producing activities. They are reassessed using the Oswestry disability Index score (ODI) one month later at their two month visit.
    Measure Participants 62 62
    Median (Inter-Quartile Range) [score on a scale]
    36
    23.11
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE)
    Comments Oswestry low back pain and disability (ODI) score change over two months for all participants. This compares the score at initial visit and the score 2 months later after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. =(ODI time 0 - ODI 2 months). The greater the difference, the better the recovery of back function.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Kruskal-Wallis
    Comments
    3. Secondary Outcome
    Title Brief Pain Inventory Score Change Over One Month. Baseline Score Minus 1 Month Score. Comparison: Immediate Corrective Exercise or Pelvic Stabilization Belt V Delayed: Usual Care
    Description Change in BPI pain score between baseline assessment visit and visit one month later: on a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours: • on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the one month visit means a better outcome.
    Time Frame 1 month after initial visit (baseline BPI pain score minus one-month BPI pain score) with each group using their assigned treatment

    Outcome Measure Data

    Analysis Population Description
    People with low back pain and malrotated sacroiliac joints.
    Arm/Group Title Immediate Corrective Exercises Immediate Use of Pelvic Support Belt Delayed Treatment
    Arm/Group Description After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are: Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later. These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt. The concurrent use of both treatments will be assessed at their last visit one month after that. Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention.
    Measure Participants 21 21 20
    Median (Inter-Quartile Range) [score on a scale]
    1.25
    1
    0.25
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt, Delayed Treatment
    Comments The null hypothesis assumes that after one month, there is no difference in brief pain inventory score improvement between the three treatment groups.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.17
    Comments
    Method Kruskal-Wallis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Delayed Treatment
    Comments The brief pain inventory score at the one month visit, is used to compare the pain levels of those having done one month of corrective exercises to those who continued with conventional treatments for their low back pain.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.089
    Comments Bonferroni alpha correction of p<0.0167.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Immediate Use of Pelvic Support Belt, Delayed Treatment
    Comments The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatment
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.092
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    4. Secondary Outcome
    Title Brief Pain Inventory (BPI) Pain Score Change Over Two Months Comparison: Baseline (BPI) Pain Score Minus 2 Month (BPI) Pain Score, After One Month Of Using Corrective Exercise + Pelvic Stabilization Belt
    Description Change in BPI pain score between baseline visit and visit minus BPI pain score two months later after one month of using corrective exercise + pelvic stabilization belt On a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours: • on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the later visit means a better outcome.
    Time Frame 2 months after baseline visit when all groups have used both the pelvic stabilization belt and the corrective exercise for one month

    Outcome Measure Data

    Analysis Population Description
    People with low back pain and malrotated sacroiliac joints.
    Arm/Group Title Initial Brief Pain Inventory (BPI) Pain Score Corrective Exercises (SIFFTE) Plus Sacroiliac Belt Use For One Month: Effect on (BPI) Pain Score
    Arm/Group Description At their initial visit, all participants fill out the brief pain inventory (BPI) pain score: on a scale of 0 (no pain) to 10 (worst imaginable pain) pain in the last 24 hours: • on average • at its worst • at its best • right now. Average of these values. Minimum value, 0, maximum value, 10. Higher scores mean a worse outcome. A higher change between the initial visit and the one month visit means a better outcome. All participants fill out the brief pain inventory pain score (BPI) then get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine levels (PSISL) are found and measured. A higher painful PSIS has anterior, a lower one has posterior malrotation. They are given the appropriate exercise (PSISE) to correct their sacroiliac malrotation. Anterior rotation is corrected with the flexed thigh pushing hard on the anterior superior iliac spine to force it posteriorly. Posterior rotation is corrected by hyperextending the thigh, using the sartorius and the rectus femoris to pull the ilium anteriorly. 3 techniques: - genuflection, anterior side foot and posterior side knee on the floor, hands on either side of the foot, knee stretched backwards, - anterior side foot on chair, pull up on chair to force the thigh against the ilium, - in dorsal decubitus assistant with anterior side foot on their sternum leans forward to push the thigh against ilium and pushes down on extended posterior side thigh to overstretch it. All these are held for 2 minutes. They are then fitted with a sacroiliac stabilization belt to wear as needed for back pain producing activities. They are reassessed one month later at their two month visit once again using the BPI pain score.
    Measure Participants 62 62
    Median (Inter-Quartile Range) [score on a scale]
    5.88
    3.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments All participants are assessed as a single group as they receive the same two treatments for one month. Brief pain inventory (BPI) score change over two months for all participants. This compares BPI score at baseline visit and BPI score 2 months later, after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. The score is between 0 and 10. The higher the change in score the greater the pain relief.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Kruskal-Wallis
    Comments
    5. Secondary Outcome
    Title Distance Between The Posterior Superior Iliac Spine Levels (PSISL) Using The Sacroiliac Forward Flexion (SIFFT) Test Comparing Corrective Exercise, Pelvic Belt, Conventional Treatment: Baseline Value Minus 1 Month Value..
    Description Difference in distance in centimetres between the levels of the higher & the lower posterior superior iliac spines as measured using a carpenter's level between the value found on admission and that found one month later (PSISL). The minimum is 0 cm, the maximum is 3.5 cm. Higher scores mean a worse outcome. The greater difference when the distance is calculated between admission and one or two months later means a better outcome.
    Time Frame One month comparing the different treatments at baseline and one month later.

    Outcome Measure Data

    Analysis Population Description
    People with back pain and malrotated sacroiliac joints
    Arm/Group Title Immediate Corrective Exercises (SIFFTE) Immediate Use of Pelvic Support Belt Delayed Treatment
    Arm/Group Description The sacroiliac forward flexion test (SIFFT) will determine the level of each posterior superior iliac spine (PSISL). The distance in centimetres between the levels of the PSISs will be recorded. Depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are: Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed with the PSISL one month later. At that time they will be given the pelvic support belt. The concurrent use of both treatments will be assessed at their last visit one month later using the PSISL. The sacroiliac forward flexion test (SIFFT) will determine the level of each posterior superior iliac spine (PSISL). The distance in centimetres between the levels of the PSISs will be recorded. Following this, participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later with the PSISL. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed with the PSISL at their last visit one month later. The sacroiliac forward flexion test (SIFFT) will determine the level of each posterior superior iliac spine (PSISL). The distance in centimetres between the levels of the PSISs will be recorded. These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the corrective exercise (SIFFTE) and the pelvic support belt after their PSISL has been recorded. The concurrent use of both treatments will be assessed using the PSISL at their last visit one month after that. Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention.
    Measure Participants 21 21 20
    Median (Inter-Quartile Range) [cm]
    1.375
    1.125
    0.25
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt, Delayed Treatment
    Comments The null hypothesis assumes there is no improvement after one month in posterior superior iliac spine levels (PSISL) measured using the sacroiliac forward flexion test (SIFFT) between the three treatment groups.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.016
    Comments The Bonferroni alpha correction is used p<0.0167
    Method Kruskal-Wallis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Delayed Treatment
    Comments The null hypothesis is that there is no difference in the distance between the posterior sacroiliac spine levels (PSISL) between those who use their usual low back pain treatments and those who are given the corrective exercises (SIFFTE) and use them as needed for one month.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments The Bonferroni alpha correction is used p<0.0167
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Immediate Use of Pelvic Support Belt, Delayed Treatment
    Comments The null hypothesis is that that using a pelvic support belt will not help correct sacroiliac joint asymmetry as measured using the distance between the posterior superior iliac spine levels (PSISL), baseline and one month later better than conventional treatment for low back pain.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments Bonferroni correction p< 0.0167
    Method Wilcoxon (Mann-Whitney)
    Comments
    6. Secondary Outcome
    Title Distance Between The Posterior Superior Iliac Spine Levels (PSISL) Using The Sacroiliac Forward Flexion (SIFFT) Test, Baseline Minus One Month After Using Corrective Exercise (SIFFTE) + Pelvic Stabilization Belt.
    Description The distance between the levels (determined using a carpenter's level) of the higher & the lower posterior superior iliac spines (PSISL) was measured in centimetres. The outcome measure is the difference between the value found on admission and that (PSISL) value found two months later after all participants have use the corrective exercises (SIFFT E) and the sacroiliac stabilizer belt for one month. The minimum is 0 cm, the maximum is 3.5 cm. On admission, higher scores mean a worse outcome. The greater difference when the distance is calculated between admission and two months later means a better outcome.
    Time Frame 2 months: comparing baseline values and values after all participants have used the corrective exercise and the sacroiliac stabilization belt for one month.

    Outcome Measure Data

    Analysis Population Description
    People with back pain and malrotated sacroiliac joints. Corona virus pandemic prevented 28 participants from returning for a final examination.
    Arm/Group Title Baseline Recording of the Distance Between Posterior Superior Iliac Spine Levels (PSISL) Immediate Corrective Exercises And Use Of Pelvic Stabilization Belt For One Month
    Arm/Group Description On admission into the study, all participants get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine (PSIS) levels are found and the distance between them is measured in centimetres. At their second visit, one month after the baseline visit, all participants get the sacroiliac forward flexion test (SIFFT): standing, trunk forward flexed the posterior superior iliac spine (PSIS) levels are found and the distance between these is recorded (PSISL). A higher painful PSIS has anterior, a lower one has posterior malrotation. They are given the appropriate exercise to correct their sacroiliac malrotation. Anterior rotation is corrected with the flexed thigh pushing hard on the anterior superior iliac spine to force it posteriorly. Posterior rotation is corrected by hyperextending the thigh, using the sartorius and the rectus femoris to pull the ilium anteriorly. 3 techniques: - genuflection, anterior side foot and posterior side knee on the floor, hands on either side of the foot, knee stretched backwards, - anterior side foot on chair, pull up on chair to force the thigh against the ilium, - in dorsal decubitus assistant with anterior side foot on their sternum leans forward to push the thigh against ilium and pushes down on extended posterior side thigh to overstretch it. All these are held for 2 minutes. They are then fitted with a sacroiliac stabilization belt to wear as needed for back pain producing activities. They are reassessed (PSISL) one month later at their two month visit.
    Measure Participants 33 33
    Median (Inter-Quartile Range) [cm]
    1.2
    0.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments Since all participants have received the same 2 treatment for one month, we will treat them as a single group. We will measure the distance between their posterior superior iliac spine levels (PSISL) when they enter the study and two months later after they have used the corrective exercise and the sacroiliac belt for one month. Corona prevented some participants from returning for examination, which this test requires. Only 11 participants were present in each group: 33 participants tested.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.0001
    Comments
    Method t-test, 2 sided
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value < 0.001
    Comments
    Method Kruskal-Wallis
    Comments
    7. Post-Hoc Outcome
    Title Satisfaction Level With Physiotherapy Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month
    Description At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with physiotherapy?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome.
    Time Frame 2 months

    Outcome Measure Data

    Analysis Population Description
    Participants in the study who had received physiotherapy treatments prior to entering the study.
    Arm/Group Title Satisfaction With Physiotherapy Satisfaction With Corrective Exercise (SIFFTE) and Pelvic Belt
    Arm/Group Description Participants joining the study having previously received physiotherapy treatments. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). After the sacroiliac forward flexion test (SIFFT) determined the position of each innominate bone, depending on their ability, subjects were given 1 of 3 exercises (SIFFTE) to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. One of 3 different exercises was used depending on the participants' ability to perform them. The position is held for 2 minutes. They used the exercise as needed for pain control. Participants were also given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They used this belt for activities which had in the past precipitated back pain. They were reassessed one month later. At that time, they were asked how satisfied they were with each treatment on a scale from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied) and which treatment they preferred, exercise, belt, both or neither. The score for the preferred therapy was recorded.
    Measure Participants 47 47
    Mean (Standard Deviation) [score on a scale]
    1.02
    (0.89)
    2.32
    (0.81)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments the null hypothesis is that all participants were as satisfied with the physiotherapy as they were with using the corrective exercises and the pelvic stabilization belt
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments
    Method t-test, 2 sided
    Comments
    8. Post-Hoc Outcome
    Title Satisfaction Level With Acupuncture Baseline Compared To Satisfaction Level With The Corrective Exercise (SIFFTE) Plus The Pelvic Support Belt Used For One Month
    Description At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with acupuncture?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome.
    Time Frame 2 months

    Outcome Measure Data

    Analysis Population Description
    All participants who entered the study having previously received acupuncture
    Arm/Group Title Satisfaction With Acupuncture Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt
    Arm/Group Description Participants joining the study having previously received acupuncture treatments. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). After the sacroiliac forward flexion test (SIFFT) determined the position of each innominate bone, depending on their ability, subjects were given 1 of 3 exercises (SIFFTE) to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. One of 3 different exercises was used depending on the participants' ability to perform them. The position is held for 2 minutes. They used the exercise as needed for pain control. Participants were also given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They used this belt for activities which had in the past precipitated back pain. They were reassessed one month later. At that time, they were asked how satisfied they were with each treatment on a scale from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied) and which treatment they preferred, exercise, belt, both or neither. The score for the preferred therapy was recorded.
    Measure Participants 34 34
    Mean (Standard Deviation) [score on a scale]
    0.97
    (0.71)
    2.41
    (0.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments the null hypothesis is that all participants were as satisfied with the acupuncture as they were with using the corrective exercises and the pelvic stabilization belt
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments
    Method t-test, 2 sided
    Comments
    9. Post-Hoc Outcome
    Title Satisfaction Level With Yoga Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month
    Description At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with doing yoga?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome.
    Time Frame 2 months

    Outcome Measure Data

    Analysis Population Description
    All participants who entered the study having previously participated in yoga exercises
    Arm/Group Title Satisfaction With Yoga Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Beltbelt
    Arm/Group Description Participants joining the study having previously participated in yoga exercises. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). As part of this study they were given the corrective exercise for their malrotated sacroiliac joint as well as the pelvic stabilization belt and used these for one month. After this month, two months after joining the study, they rated their satisfaction with the corrective exercise (SIFFTE) from 0 - 3 and with the pelvic stabilization belt from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). They were then asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used.
    Measure Participants 27 27
    Mean (Standard Deviation) [score on a scale]
    0.92
    (0.83)
    2.37
    (0.84)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments The null hypothesis is that all participants were as satisfied with the yoga exercises as they were with using the corrective exercises and the pelvic stabilization belt
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments
    Method t-test, 2 sided
    Comments
    10. Post-Hoc Outcome
    Title Satisfaction Level With Core Exercises Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month
    Description At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with doing core exercises?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome.
    Time Frame 2 months

    Outcome Measure Data

    Analysis Population Description
    All participants who entered the study having previously performed core exercises
    Arm/Group Title Satisfaction With Core Exercises Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt
    Arm/Group Description Participants joining the study having previously participated in core exercises. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). As part of this study they were given the corrective exercise (SIFFTE) for their malrotated sacroiliac joint as well as the pelvic stabilization belt and used these for one month. After this month, two months after joining the study, they rated their satisfaction with the corrective exercise (SIFFTE) from 0 - 3 and with the pelvic stabilization belt from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). They were then asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. Wow that's impressive her be and I have done have been 10,802 and 41
    Measure Participants 38 38
    Mean (Standard Deviation) [score on a scale]
    1.08
    (0.78)
    2.21
    (0.81)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments the null hypothesis is that all participants were as satisfied with the core exercises as they were with using the corrective exercise and the pelvic stabilization belt
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments
    Method t-test, 2 sided
    Comments
    11. Post-Hoc Outcome
    Title Satisfaction Level With Chiropractic Manipulation Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used for One Month
    Description At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with the treatments you received from your chiropractor?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome.
    Time Frame 2 months

    Outcome Measure Data

    Analysis Population Description
    All participants who entered the study having previously received treatment by a chiropractor
    Arm/Group Title Satisfaction With the Treatments Received From a Chiropractor Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt
    Arm/Group Description Participants joining the study having previously received chiropractic treatments. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). As part of this study they were given the corrective exercise (SIFFTE) for their malrotated sacroiliac joint as well as the pelvic stabilization belt and used these for one month. After this month, two months after joining the study, they rated their satisfaction with the corrective exercise (SIFFTE) from 0 - 3 and with the pelvic stabilization belt from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). They were then asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used.
    Measure Participants 42 42
    Mean (Standard Deviation) [score on a scale]
    1
    (0.91)
    2.28
    (0.83)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments the null hypothesis is that all participants were as satisfied with treatments by a chiropractor as they were with using the corrective exercise and the pelvic stabilization belt
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments
    Method t-test, 2 sided
    Comments
    12. Post-Hoc Outcome
    Title Satisfaction Level With Massage Therapy Baseline Compared to Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt Used For One Month
    Description At baseline, participants answered the satisfaction questionnaire: "on a scale of 0 - 3 where 0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always, how satisfied were you with massage therapy?" Two months later, after using the corrective exercise (SIFFTE) and the pelvic support belt for one month they were asked the same satisfaction questions for the corrective exercise (SIFFTE) and the pelvic support belt, following which they were asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used. The minimum value was 0, the maximum value was 3. Higher scores mean a better outcome.
    Time Frame 2 months

    Outcome Measure Data

    Analysis Population Description
    All participants who entered the study having previously received massage therapy
    Arm/Group Title Satisfaction With Massage Therapy Satisfaction With Corrective Exercises (SIFFTE) and Pelvic Support Belt
    Arm/Group Description Participants joining the study having previously received massage therapy. On joining the study they rated their satisfaction with this treatment from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). As part of this study they were given the corrective exercise (SIFFTE) for their malrotated sacroiliac joint as well as the pelvic stabilization belt and used these for one month. After this month, two months after joining the study, they rated their satisfaction with the corrective exercise (SIFFTE) from 0 - 3 and with the pelvic stabilization belt from 0 - 3. (0 = not at all, 1 = sometimes, 2 = most of the time, 3 = always satisfied). They were then asked whether they preferred the exercise, the belt, both or neither. If they chose the exercise, the satisfaction score for the exercise was used, if they chose the belt the satisfaction score for the belt was used, if they chose both the higher satisfaction score was used, if they chose neither the lower satisfaction score was used.
    Measure Participants 42 42
    Mean (Standard Deviation) [score on a scale]
    1.19
    (0.86)
    2.36
    (0.73)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Immediate Corrective Exercises (SIFFTE), Immediate Use of Pelvic Support Belt
    Comments The null hypothesis is that all participants were as satisfied with massage therapy as they were with using the corrective exercise and the pelvic stabilization belt.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.00001
    Comments
    Method t-test, 2 sided
    Comments

    Adverse Events

    Time Frame The timeframe was two months from the time of the baseline assessment and assignment to a treatment group to 2 months later after all participants had used both the corrective exercises (SIFFTE) and the pelvic stabilization belt for one month.
    Adverse Event Reporting Description
    Arm/Group Title Immediate Corrective Exercises Immediate Use of Pelvic Support Belt Delayed Treatment
    Arm/Group Description After the sacroiliac forward flexion test (SIFFT) has determined the position of each innominate bone, depending on their ability, subjects are given 1 of 3 exercises to correct their sacroiliac malrotation. All 3 correct anterior malrotation, by flexing the thigh hard against the ilium, pushing it posteriorly. Posterior malrotation, is corrected by hyperextending the thigh, using the sartorius and rectus femoris to pull the ilium anteriorly. These exercises are: Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. In supine position anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. For anterior malrotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold the position for 2 minutes. They will use the exercise as needed for pain control and will be reassessed one month later. At that time they will be given the pelvic support belt and the concurrent use of both treatments will be assessed at their last visit one month after that. Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later. At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later. These participants will continue using their current therapies to deal with their low back pain for one month prior to being scheduled for a treatment visit. At the treatment visit, one month later they will be given both the exercise and the belt. The concurrent use of both treatments will be assessed at their last visit one month after that. Delayed treatment: Participants will continue the treatments they are currently using to relieve their low back pain for one month prior to being treated with the intervention.
    All Cause Mortality
    Immediate Corrective Exercises Immediate Use of Pelvic Support Belt Delayed Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 0/21 (0%) 0/20 (0%)
    Serious Adverse Events
    Immediate Corrective Exercises Immediate Use of Pelvic Support Belt Delayed Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 0/21 (0%) 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    Immediate Corrective Exercises Immediate Use of Pelvic Support Belt Delayed Treatment
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 6/21 (28.6%) 0/20 (0%)
    Musculoskeletal and connective tissue disorders
    Unspecified pain 0/21 (0%) 0 4/21 (19%) 4 0/20 (0%) 0
    Skin and subcutaneous tissue disorders
    rash, skin irritation 0/21 (0%) 0 2/21 (9.5%) 2 0/20 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Helene Bertrand
    Organization University of British Columbia Department of Family Practice
    Phone 7782277776
    Email dr.hbertrand@gmail.com
    Responsible Party:
    Helene Bertrand, Principal Investigator, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT03888235
    Other Study ID Numbers:
    • H19-01224
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021