- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06017804
Muscle Energy Technique and Foam Roller Self Myofascial Release in Two-wheeler Riders With Chronic Low Back Pain
August 31, 2023 updated by: AMIR IQBAL, King Saud University
A Comparative Study of Muscle Energy Technique and Foam Roller Self-myofascial Release for Chronic Low Back Pain in Two-wheeler Riders
Pain in the lower back is a major concern in today's era due to prolonged sitting in two-wheeler riders, mainly due to hamstring tightness.
It also creates physical disability and impairment in activities of daily living.
This study aimed to compare the efficacy of muscle energy technique (MET) and self-myofascial release (SMFR) using the foam roller on hamstring flexibility, dynamic balance, and physical disability amongst two-wheeler riders with chronic low back pain.
Participants were randomized into two intervention groups, MET and SMFR, using the envelope method, with each group having 20 participants.
Hamstring flexibility and range of motion for knee extension and the lower back were assessed using the active knee extension test and sit and reach test, the dynamic balance was assessed by the star excursion balance test (SEBT) and physical disability by Roland-Morris Disability Questionnaire, (RMDQ).
Measurements were taken at baseline and after 4-week of intervention.
The level of significance value was set at 95% (p <0.05).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The present study proved that both SMFR using the foam roller and MET are effective in improving hamstring muscle flexibility, dynamic balance, and physical disability in two-wheeler riders with chronic low back pain.
Thus, either of the two techniques can be used for treating bikers with tight hamstrings causing chronic low back pain.
Compared to MET, SMFR using foam rollers was found to be more effective in enhancing hamstring flexibility, improving balance, and decreasing disability levels on the RMDQ after 4 weeks.
This study will be aware of the necessity of hamstring stretching and balance training among two-wheeler riders for a prolonged duration on a daily basis and take the initiative to improve their hamstring flexibility and balance.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Riyadh, Saudi Arabia, 11433
- Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Two-wheeler riders of either gender between the ages of 20 and 40 years,
- Who had ridden at least two hours per day for the previous two years,
- Had musculoskeletal pain in the back for the previous three months, and
- Had a 15-20-degree loss of knee extension when hips were held in 90-degree flexion.
Exclusion Criteria:
- Pregnant women,
- Those with a recent spine or lower limb fracture, recent surgery,
- A previous hamstring injury,
- Lumbar and lower limb neurological deficits, or limb length disparity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MET Group
Received a muscle energy technique
|
Participants were required to adopt a supine position.
MET's post-isometric relaxation method was chosen.
The therapist gently flexed the patient's hip until the limitation bar-rier was detected.
At this stage, isometric contractions against resistance were applied.
After that, the patients were told to resist the movement with only 25% of their strength.
Before the leg was released, the contraction was maintained for 7-10 seconds.
On exhale, the knee joint was straightened (extended) towards its new barrier, and a stretch was applied and maintained through that barrier for 30 seconds.
This procedure was carried out six times.
|
|
Active Comparator: SMFR Group
Received a self-myofascial release technique using a foam roller
|
A foam roller was rolled from the ischial tuberosity to the back of the knee on the side being tested while the participant remained seated in a long sitting position.
Individuals were instructed to keep all of their body weight on the leg being evaluated.
They spent 30-40 seconds rolling one hamstring at a time in each set (10 times back and forth).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamstring flexibility
Time Frame: 4 weeks
|
Hamstring flexibility was assessed using an active knee extension test (AKET) at baseline and four weeks post-intervention.
|
4 weeks
|
|
Active range of motion
Time Frame: 4 weeks
|
Active range of motion was assessed using a sit and reach test (SRT) at baseline and four weeks post-intervention.
|
4 weeks
|
|
Dynamic balance
Time Frame: 4 weeks
|
Dynamic balance was assessed using a star excursion balance test (SEBT) at baseline and four weeks post-intervention.
|
4 weeks
|
|
Roland-Morris Disability Questionnaire Scale
Time Frame: 4 weeks
|
Roland-Morris Disability Questionnaire (RMDQ) was used assessing the physical disability at baseline and four weeks post-intervention.
The RMQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24; higher scores represent higher levels of pain-related disability.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: AMIR IQBAL, MPT, King Saud University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2022
Primary Completion (Actual)
September 23, 2022
Study Completion (Actual)
November 29, 2022
Study Registration Dates
First Submitted
August 24, 2023
First Submitted That Met QC Criteria
August 24, 2023
First Posted (Actual)
August 30, 2023
Study Record Updates
Last Update Posted (Estimated)
September 6, 2023
Last Update Submitted That Met QC Criteria
August 31, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRIIRS/FAHS/PT/2022-23/M-010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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