Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT05282589

Collaborator

(none)

Enrollment

Location

Arms

4.2

Actual Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is determine the effects of lumbopelvic manipulation on fatigue, pain and disability in chronic low back pain patients. In this randomised clinical trial, lumbopelvic manipulation group was compared with conventional therapy group. Tools used in the study are numeric pain rating scale ,oswestry low back pain index and rating of fatigue scale.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Other: lumbopelvic manipulation and conventional therapy Other: conventional therapy	N/A

Detailed Description

Low back pain is an extremely common problem which causes morbidity in adults. It is more likely to occur in individuals around the age 20 to 60, this is partly due to the changes that occurs with aging. It can be acute (less than 12 weeks) or chronic (more than 12 weeks). There are many causes of low back pain one of the most common is the lumber disc herniation. Some of the most serious causes of low back pain include (infection, malignancy, vertebral fracture, cauda equina syndrome and inflammatory disorders such as axial spondyloarthritis). Mostly low backpain can be a result of injury such as muscle strain or sprains due to sudden movements or poor body mechanics while lifting heavy loads. Pain in low back can be the result of infection effecting the bony lumber spine, ligaments around the spine, the spinal cord, nerves and muscles of the spine, internal organs and skin around the spine.

Treatment for low back pain falls into three broad categories, multidisciplinary therapy is based on intensive exercises that improves physical function and has modest effects on pain physiotherapy treatment of low back pain includes laser, massage, multidisciplinary rehabilitation and spinal manipulation. Spinal manipulation is a high velocity thrust to a joint beyond its restricted range of movement. Spinal manipulation to lumber spine is a common intervention administered for patients with low back pain.

There is limited use of the technique in our society especially finding its effects on fatigue in chronic low back pain.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel assignmentparallel assignment

Masking:

Single (Participant)

Masking Description:

single blinded means that the participants have no idea of what treatment they are receiving and to which group they belong.

Primary Purpose:

Treatment

Official Title:

Effects Of Lumbopelvic Manipulation On Fatigue In Chronic Low Back Pain Patients

Actual Study Start Date :

Sep 21, 2021

Actual Primary Completion Date :

Jan 15, 2022

Actual Study Completion Date :

Jan 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lumbopelvic manipulation and conventiontional therapy Group A an experimental group was given conventional therapy and lumbopelvic manipulation. conventional therapy include TENS and Hot pack for 20 minutes , hamstrings stretching, calf stretching,transversus abdominis strengthening and lumber multipedes muscle strengthening. while lumbopelvic manipulation include high velocity thrust given in posterior direction to ASIS.	Other: lumbopelvic manipulation and conventional therapy Lumbopelvic manipulation was given along with conventional physical therapy Transcutaneous Electrical Nerve Stimulation was applies for 15 minutes. 3 alternate days per week. Static stretching exercises for targeted muscles Erector spinae, hamstrings and calfs) - 4 repetations X 2 sets with 30 seconds hold and 1 minute of resting interval. On 03 alternate days per week. Strengthening exercises for traverses abdomminis and lumber multipedus muscles - 15 repetitions X 3 sets. On 03 alternate days per week. Total 12 session were given, each consisting of 45 minutes.
Active Comparator: conventional therapy Group B, control group was given only conventional therapy which include TENS and Hot pack for 20 minutes , hamstrings stretching, calf stretching,transversus abdominis strengthening and lumber multipedes muscle strengthening . 1 set of 10 repetitions, 3 sessions per week with a total of 12 sessions.	Other: conventional therapy Transcutaneous Electrical Nerve Stimulation was applies for 15 minutes. 3 alternate days per week. Static stretching exercises for targeted muscles Erector spinae, hamstrings and calfs) - 4 repetations X 2 sets with 30 seconds hold and 1 minute of resting interval. On 03 alternate days per week. Strengthening exercises for traverses abdomminis and lumber multipedus muscles - 15 repetitions X 3 sets. On 03 alternate days per week. Total 12 session were given, each consisting of 45 minutes.

Arm

Intervention/Treatment

Experimental: Lumbopelvic manipulation and conventiontional therapy

Group A an experimental group was given conventional therapy and lumbopelvic manipulation. conventional therapy include TENS and Hot pack for 20 minutes , hamstrings stretching, calf stretching,transversus abdominis strengthening and lumber multipedes muscle strengthening. while lumbopelvic manipulation include high velocity thrust given in posterior direction to ASIS.

Other: lumbopelvic manipulation and conventional therapy

Lumbopelvic manipulation was given along with conventional physical therapy Transcutaneous Electrical Nerve Stimulation was applies for 15 minutes. 3 alternate days per week. Static stretching exercises for targeted muscles Erector spinae, hamstrings and calfs) - 4 repetations X 2 sets with 30 seconds hold and 1 minute of resting interval. On 03 alternate days per week. Strengthening exercises for traverses abdomminis and lumber multipedus muscles - 15 repetitions X 3 sets. On 03 alternate days per week. Total 12 session were given, each consisting of 45 minutes.

Active Comparator: conventional therapy

Group B, control group was given only conventional therapy which include TENS and Hot pack for 20 minutes , hamstrings stretching, calf stretching,transversus abdominis strengthening and lumber multipedes muscle strengthening . 1 set of 10 repetitions, 3 sessions per week with a total of 12 sessions.

Other: conventional therapy

Transcutaneous Electrical Nerve Stimulation was applies for 15 minutes. 3 alternate days per week. Static stretching exercises for targeted muscles Erector spinae, hamstrings and calfs) - 4 repetations X 2 sets with 30 seconds hold and 1 minute of resting interval. On 03 alternate days per week. Strengthening exercises for traverses abdomminis and lumber multipedus muscles - 15 repetitions X 3 sets. On 03 alternate days per week. Total 12 session were given, each consisting of 45 minutes.

Outcome Measures

Primary Outcome Measures

Fatigue assessment scale (FAS) [4th week]
Among the ten questions of the FAS. Every point of has further five components in which 1 means "never" and 5 means "always". Its scoring is from 10-50 in which 10 showing lowest fatigue level and 50 means indicating highest fatigue level. If the overall score is less than 22 it denotes no fatigue while if the score is more than 22 it will show the presence of substantial fatigue.

Secondary Outcome Measures

Numeric pain rating scale (NPRS) [4th week]
Numeric pain rating scale is 11 point scale which consists of a straight or linear line running from left to right with a range from 0 -10 in which the digit 0 which lies on the left means no pain while the digit 10 lying on the right means the worst pain.
Oswestry low back pain questionnaire [4th week]
The oswestry low back pain questionnaire is believed to be specially designed for back related disability in daily life activities in 10 queries with a substitutes for verbal response. Its ranking is from 0-100 in which 0 means there is no disability at time and 100 score means absolutely or entirely disabled.
Range of Motion [4th week]
It was measured by bubble inclinometer. For taking the ranges of flexion and extension 12th thoracic and 1st sacral vertebrae were taken as the reference points. Two bubble inclinometers were used at the same time in standing position.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

females patients having fatigue along with chronic low back pain low back pain for more than three months age 20-60

Exclusion Criteria:

patients with conditions other than chronic low back pain having radiculopathy history of serious underlying pathology such as nerve root compromise, structural deformities, genetic spinal disorders and previous spinal surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pakistan Railway General Hospital	Rawalpindi	Punjab	Pakistan	46010

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Muhammad Affan Iqbal, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05282589

Other Study ID Numbers:

Rphah/RCRS/REC/01057

First Posted:

Mar 16, 2022

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Mar 16, 2022