Mechanisms of Specific Trunk Exercises in Low Back Pain

• Sponsor: University of Vermont (Other)
• Overall Status: Completed
• CT.gov ID: NCT01362049
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 102
• Location: 1
• Arms: 4
• Duration (Months): 45
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The research objective is to determine which physical therapy (PT) treatment is the most efficacious for patients with lower back pain (LBP), who have been subgrouped based on certain clinical features. There is only limited evidence that supports any one PT treatment for patients with LBP since PT treatment outcomes for exercise protocols are equivocal, given the heterogeneous clinical features of patients with LBP. Thus, classification of patients with LBP into subgroups with shared clinical features has been identified as a research priority by several groups in order to prescribe the most efficacious PT treatment for each homogeneous subgroup. The investigators hypothesize that particular PT treatments are most efficacious when applied to patients with LBP, who present with particular clinical and neuromuscular features.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Physical Therapy rehabilitation: Stabilization exercises.; Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise	N/A

Detailed Description

The proposed studies focus on 2 schemas to classify LBP: 1) the Treatment-Based Classification (TBC) system, from which clinical prediction rules about who is most likely to benefit from spinal stabilization exercises (among others) have been developed, and 2) the Movement System Impairment-Based Classification (MSI) system, which includes 5 classifications of LBP named for the specific direction(s) of movements and alignments associated with the person's LBP.

The primary purpose of this proposal is to conduct a prospective, randomized, controlled Phase II clinical trial in order to examine whether or not treatment matched to a patient's specific signs and symptoms (patient-matched) per the TBC is more effective than the MSI system for improving short- (6 weeks) and long-term (12 and 24 months) outcomes in people with chronic LBP. A secondary purpose is to identify prognostic factors that predict clinical outcomes in the 2 treatment groups being compared.

Subjects will be assigned to one of two study arms:

1. eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria ('Eligible' Subject Group); and

2. subjects who are not eligible for the TBC-based stabilization exercises ('Ineligible' Subject Group).

Within in each study arm, subjects will be randomly assigned to 1 of 2 exercise protocols for a 6-week period:

1. stabilization - a protocol focused on improving the motor control of trunk muscles to stabilize the spine; or

2. MSI-based - a classification-specific treatment focused on education and instruction for modifying movement strategies during functional activities, and on exercises specific to the classification category.

Laboratory measures (muscle activation, kinematics, forces) during standardized tasks will quantify neuromuscular impairments associated with LBP and clinical questionnaires will quantify changes in pain, function, and health status pre- and post-treatment. The addition of neuromuscular measures to these classification schemas could improve the sensitivity and specificity of each.

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mechanisms of Specific Trunk Exercises in Low Back Pain
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 'Eligible' Subject Group - STAB Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level.	Other: Physical Therapy rehabilitation: Stabilization exercises.; The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.; Other Names: Trunk stabilization exercises Segmental stabilization exercises
Active Comparator: 'Ineligible' Subject Group - STAB Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria	Other: Physical Therapy rehabilitation: Stabilization exercises.; The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.; Other Names: Trunk stabilization exercises Segmental stabilization exercises
Active Comparator: 'Eligible' Subject Group - MSI Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level.	Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise; The MSI-classification based approach focuses on education and instruction for modifying movement strategies during functional activities, and on exercises that are specific to the classification category. First there is an analysis of and instruction in modifying a subject's direction-specific alignment and movement strategies during symptomatic functional activities. Second, there is education about the principles of tissue injury and healing, and how cumulative tissue stress contributes to microtrauma and LBP. Unique to the education process is the emphasis on how using one's particular movement strategies during functional activities may accelerate tissue stress accumulation because the strategies are used repetitively. Thirdly, there is exercise prescription that includes practice in performing modified versions of the direction-specific impairment tests from the physical exam, with an emphasis on impairments that can be modified to eliminate LBP symptoms.; Other Names: Specific exercise Sarhmann exercise approach MSI exercises
Active Comparator: 'Ineligible' Subject Group -MSI Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria	Other: Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise; The MSI-classification based approach focuses on education and instruction for modifying movement strategies during functional activities, and on exercises that are specific to the classification category. First there is an analysis of and instruction in modifying a subject's direction-specific alignment and movement strategies during symptomatic functional activities. Second, there is education about the principles of tissue injury and healing, and how cumulative tissue stress contributes to microtrauma and LBP. Unique to the education process is the emphasis on how using one's particular movement strategies during functional activities may accelerate tissue stress accumulation because the strategies are used repetitively. Thirdly, there is exercise prescription that includes practice in performing modified versions of the direction-specific impairment tests from the physical exam, with an emphasis on impairments that can be modified to eliminate LBP symptoms.; Other Names: Specific exercise Sarhmann exercise approach MSI exercises

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Oswestry Disability Scale (0-100%) [Baseline and 7 weeks]

   Disability; Sacle 0-100% Lower score is considered better/improved

2. Change From Baseline in Oswestry Disability Scale (0-100%) [Baseline and 12 Months]

   Disability; Sacle 0-100% Lower score is considered better/improved

3. Change From Baseline in Numeric Pain Rating Scale (0-10 Points) [Baseline and 7 weeks]

   Current Pain Scale 0-10 Lower score is better/improved

4. Change From Baseline in Numeric Pain Rating Scale (0-10 Points) [Baseline and 12 months]

   Current Pain Scale 0-10 Lower score is better/improved

Secondary Outcome Measures

1. Change From Baseline in SF-36 Health Survey (0 - 100 Points) [Baseline and 7 weeks]

   Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state

2. Change From Baseline in SF-36 Health Survey (0-100 Points) [Baseline and 12 months]

   Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state

3. Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points) [Baseline and 7 weeks]

   fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty

4. Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points) [Baseline and 12 months]

   fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• a history of chronic LBP with or without recurrences for a minimum of 12 months;

• between 21 - 55 years of age;

• able to stand and walk without assistance;

• have an Oswestry Disability Score of 19% or higher AND/OR less than an 8 on one activity reported on the Patient Specific Functional Scale,

Exclusion Criteria:

• any major structural spinal deformity including scoliosis, kyphosis, or stenosis;

• spinal fracture or dislocation;

• osteoporosis;

• ankylosing spondylitis;

• rheumatoid arthritis;

• disc herniation with corroborating clinical signs and symptoms;

• serious spinal complications such as tumor or infection;

• previous spinal surgery;

• frank neurological loss, i.e., weakness and sensory loss;

• pain or paresthesia below the knee;

• etiology of LBP other than the lumbar spine, e.g., hip joint;

• history of neurological disease which required hospitalization;

• active treatment for cancer;

• history of unresolved cancer;

• pregnancy or less than 6 months post-partum or less than 6 months post weaning;

• magnified symptom-behavior;

• worker's compensation or disability case;

• in litigation for the LBP problem;

• have a BMI ≥ 30.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Motion Analysis Lab	Burlington	Vermont	United States	05401

Sponsors and Collaborators

• University of Vermont
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Sharon M Henry, PT, PhD, University of Vermont

Study Documents (Full-Text)

None provided.

More Information

Publications

• Boucher JA, Preuss R, Henry SM, Dumas JP, Larivière C. The effects of an 8-week stabilization exercise program on lumbar movement sense in patients with low back pain. BMC Musculoskelet Disord. 2016 Jan 14;17:23. doi: 10.1186/s12891-016-0875-4.
• Henry SM, Fritz JM, Trombley AR, Bunn JY. Reliability of a treatment-based classification system for subgrouping people with low back pain. J Orthop Sports Phys Ther. 2012 Sep;42(9):797-805. doi: 10.2519/jospt.2012.4078. Epub 2012 Jun 7.
• Henry SM, Van Dillen LR, Trombley AR, Dee JM, Bunn JY. Reliability of novice raters in using the movement system impairment approach to classify people with low back pain. Man Ther. 2013 Feb;18(1):35-40. doi: 10.1016/j.math.2012.06.008. Epub 2012 Jul 15.
• Jacobs JV, Lomond KV, Hitt JR, DeSarno MJ, Bunn JY, Henry SM. Effects of low back pain and of stabilization or movement-system-impairment treatments on induced postural responses: A planned secondary analysis of a randomised controlled trial. Man Ther. 2016 Feb;21:210-9. doi: 10.1016/j.math.2015.08.006. Epub 2015 Aug 21.
• Jacobs JV, Roy CL, Hitt JR, Popov RE, Henry SM. Neural mechanisms and functional correlates of altered postural responses to perturbed standing balance with chronic low back pain. Neuroscience. 2016 Dec 17;339:511-524. doi: 10.1016/j.neuroscience.2016.10.032. Epub 2016 Oct 19.
• Larivière C, Gagnon D, De Oliveira E Jr, Henry SM, Mecheri H, Dumas JP. Reliability of ultrasound measures of the transversus abdominis: effect of task and transducer position. PM R. 2013 Feb;5(2):104-13. doi: 10.1016/j.pmrj.2012.11.002. Epub 2013 Jan 10.
• Larivière C, Gagnon D, De Oliveira E Jr, Henry SM, Mecheri H, Dumas JP. Ultrasound measures of the lumbar multifidus: effect of task and transducer position on reliability. PM R. 2013 Aug;5(8):678-87. doi: 10.1016/j.pmrj.2013.03.010. Epub 2013 Mar 15.
• Mehta R, Cannella M, Henry SM, Smith S, Giszter S, Silfies SP. Trunk Postural Muscle Timing Is Not Compromised In Low Back Pain Patients Clinically Diagnosed With Movement Coordination Impairments. Motor Control. 2017 Apr;21(2):133-157. doi: 10.1123/mc.2015-0049. Epub 2016 Aug 19.
• Zielinski KA, Henry SM, Ouellette-Morton RH, DeSarno MJ. Lumbar multifidus muscle thickness does not predict patients with low back pain who improve with trunk stabilization exercises. Arch Phys Med Rehabil. 2013 Jun;94(6):1132-8. doi: 10.1016/j.apmr.2012.12.001. Epub 2012 Dec 7.

• Responsible Party: Sharon M. Henry, Professor, University of Vermont
• ClinicalTrials.gov Identifier: NCT01362049
• Other Study ID Numbers: CHRMS 10-045; 5R01HD040909-07
• First Posted: May 27, 2011
• Last Update Posted: Jun 5, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sharon M. Henry, Professor, University of Vermont: Stabilization exercise; Physical therapy; Rehabilitation; Movement System Impairment exercise
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

Participant Flow

Arm/Group Title	'Eligible' Subject Group - MSI Treatment	'Eligible' Subject Group - STAB Treatment	'Ineligible' Subject Group - MSI Treatment	'Ineligible' Subject Group - STAB Treatment
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI match treatment	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria. Received MSI- matched treatment	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria. Received STAB treatment
Period Title: Follow-Up at 7 Weeks
STARTED	26	19	32	25
Randomized and Started PT Treatment	26	18	32	25
COMPLETED	23	16	30	24
NOT COMPLETED	3	3	2	1
Period Title: Follow-Up at 7 Weeks
STARTED	23	16	30	24
COMPLETED	18	13	28	21
NOT COMPLETED	5	3	2	3

Baseline Characteristics

Arm/Group Title	'Eligible' Subject Group - MSI Treatment	'Eligible' Subject Group - STAB Treatment	'Ineligible' Subject Group - MSI Treatment	'Ineligible' Subject Group - STAB Treatment	Total
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-match treatment	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria. Received MSI-match treatment	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria. Received STAB treatment	Total of all reporting groups
Overall Participants	26	19	32	25	102
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	26 100%	19 100%	32 100%	25 100%	102 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.5 (11.4)	37.1 (11.4)	44.1 (9.4)	45.9 (8.8)	41.5 (10.8)
Sex: Female, Male (Count of Participants)
Female	17 65.4%	12 63.2%	12 37.5%	10 40%	51 50%
Male	9 34.6%	7 36.8%	20 62.5%	15 60%	51 50%
Region of Enrollment (participants) [Number]
United States	26 100%	19 100%	32 100%	25 100%	102 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Oswestry Disability Scale (0-100%)
Description	Disability; Sacle 0-100% Lower score is considered better/improved
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	23	16	30	23
Mean (Standard Deviation) [units on a scale]	-8.26 (7.94)	-7.75 (8.54)	-8.00 (10.47)	-9.48 (12.02)

2. Primary Outcome

Title	Change From Baseline in Oswestry Disability Scale (0-100%)
Description	Disability; Sacle 0-100% Lower score is considered better/improved
Time Frame	Baseline and 12 Months

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	18	13	28	20
Mean (Standard Deviation) [units on a scale]	-8.8 (13.8)	-14.2 (8.9)	-10.1 (9.9)	-9.7 (11.2)

3. Primary Outcome

Title	Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Description	Current Pain Scale 0-10 Lower score is better/improved
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	21	14	30	25
Mean (Standard Deviation) [units on a scale]	-.62 (2.56)	-1 (1.62)	-1.50 (1.61)	-.92 (1.55)

4. Primary Outcome

Title	Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
Description	Current Pain Scale 0-10 Lower score is better/improved
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	17	9	23	20
Mean (Standard Deviation) [units on a scale]	.18 (3.68)	-1.56 (1.94)	-1.35 (2.06)	-1.25 (1.33)

5. Secondary Outcome

Title	Change From Baseline in SF-36 Health Survey (0 - 100 Points)
Description	Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	21	15	30	24
Mean (Standard Deviation) [units on a scale]	4.40 (6.27)	3.99 (5.99)	3.34 (4.87)	1.32 (6.09)

6. Secondary Outcome

Title	Change From Baseline in SF-36 Health Survey (0-100 Points)
Description	Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	16	13	28	20
Mean (Standard Deviation) [units on a scale]	3.16 (4.48)	5.68 (6.25)	2.72 (6.11)	2.97 (6.78)

7. Secondary Outcome

Title	Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
Description	fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	23	16	30	25
Mean (Standard Deviation) [units on a scale]	-0.65 (3.8)	-0.53 (3.8)	-0.5 (5.2)	-1.15 (5.1)

8. Secondary Outcome

Title	Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
Description	fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

Participants with available data are included

Arm/Group Title	'Eligible' Subject Group - MSI	'Eligible' Subject Group - STAB	'Ineligible' Subject Group -MSI	'Ineligible' Subject Group - STAB
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.	Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
Measure Participants	18	12	28	20
Median (Standard Deviation) [units on a scale]	-3.1 (4.8)	0.6 (4.5)	-2.9 (5.3)	-1.6 (6.1)

Adverse Events

Time Frame	Baseline, 7 weeks, 1 year (12 months)
Arm/Group Title	'Eligible' Subject Group - MSI Treatment		'Eligible' Subject Group - STAB		'Ineligible' Subject Group - MSI Treatment		'Ineligible' Subject Group - STAB Treatment
Arm/Group Description	Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-matched treatment		Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria: straight leg raise > 90 degrees aberrant trunk movement with trunk forward flexion positive prone instability test AND/OR passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment		Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Received MSI-matched treatment		Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria. Received STAB treatment
All Cause Mortality
	'Eligible' Subject Group - MSI Treatment		'Eligible' Subject Group - STAB		'Ineligible' Subject Group - MSI Treatment		'Ineligible' Subject Group - STAB Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/18 (0%)		0/32 (0%)		0/25 (0%)
Serious Adverse Events
	'Eligible' Subject Group - MSI Treatment		'Eligible' Subject Group - STAB		'Ineligible' Subject Group - MSI Treatment		'Ineligible' Subject Group - STAB Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/18 (0%)		0/32 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	'Eligible' Subject Group - MSI Treatment		'Eligible' Subject Group - STAB		'Ineligible' Subject Group - MSI Treatment		'Ineligible' Subject Group - STAB Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/18 (0%)		0/32 (0%)		0/25 (0%)

Limitations/Caveats

The sample size was relatively small, providing adequate power for only comparing the matched to unmatched treatments (and not the stabilization vs. Movement System Impairment exercises).

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.