Chronic Low-back PainNCT06017804
Muscle Energy Technique and Foam Roller Self Myofascial Release in Two-wheeler Riders With Chronic Low Back Pain
A study testing Muscle energy technique and Self-myofascial release technique in people with Chronic Low-back Pain, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Muscle energy technique and Self-myofascial release technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 14 Mar 2022to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University
Riyadh, 11433
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Muscle energy technique, Self-myofascial release technique
- Keywords
- Hamstring flexibility, Muscle Energy technique, Self-myofascial release, Foam roller, Dynamic balance, Physical disability, Sit and reach test, Active knee extension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle energy techniqueOther
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.
Self-myofascial release techniqueOther
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).
| Study group | Role | What they receive |
|---|---|---|
| MET Group | Experimental | Received a muscle energy technique Receives: Other: Muscle energy technique |
| SMFR Group | Active comparator | Received a self-myofascial release technique using a foam roller Receives: Other: Self-myofascial release technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamstring flexibility
Hamstring flexibility was assessed using an active knee extension test (AKET) at baseline and four weeks post-intervention.
Measured: 4 weeks
Active range of motion
Active range of motion was assessed using a sit and reach test (SRT) at baseline and four weeks post-intervention.
Measured: 4 weeks
Dynamic balance
Dynamic balance was assessed using a star excursion balance test (SEBT) at baseline and four weeks post-intervention.
Measured: 4 weeks
Roland-Morris Disability Questionnaire Scale
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start14 Mar 2022
- Primary completion23 Sep 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- Manav Rachna International Institute of Research and Studies
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT, Study chair, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017804
- Sponsor's protocol ID
- MRIIRS/FAHS/PT/2022-23/M-010
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Muscle Energy Technique and Foam Roller Self-myofascial Release for Chronic Low Back Pain in Two-wheeler Riders
- ClinicalTrials.gov ID
- NCT06017804
- Acronym / sponsor ID
- MRIIRS/FAHS/PT/2022-23/M-010
- Conditions
- Chronic Low-back Pain
- Keywords
- Hamstring flexibility, Muscle Energy technique, Self-myofascial release, Foam roller, Dynamic balance, Physical disability, Sit and reach test, Active knee extension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- Manav Rachna International Institute of Research and Studies
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| MET Group | Experimental | Other: Muscle energy techniqueReceived a muscle energy technique |
| SMFR Group | Active comparator | Other: Self-myofascial release techniqueReceived a self-myofascial release technique using a foam roller |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle energy techniqueParticipants 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. | Other | MET Group |
| Self-myofascial release techniqueA 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). | Other | SMFR Group |
Primary outcome
Hamstring flexibility
Time frame: 4 weeks
Hamstring flexibility was assessed using an active knee extension test (AKET) at baseline and four weeks post-intervention.
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.
Dynamic balance
Time frame: 4 weeks
Dynamic balance was assessed using a star excursion balance test (SEBT) at baseline and four weeks post-intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AMIR IQBAL, MPT study chair
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle energy technique and Self-myofascial release technique in people with Chronic Low-back Pain, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamstring flexibility (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.