Chronic Low-back PainNCT05174520
Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain
A study testing Routine Physical Therapy and Muscle Energy Technique in people with Chronic Low-back Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
•Null hypothesis: There is no difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain. •Alternative hypothesis: There is difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients… Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Routine Physical Therapy and Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Oct 2021to 1 Jul 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders of age 30 to 55 year.
- Patients with pain for at least three months or more (chronic stage).
- Patients having score of at least 3 on 0-10 points(NPRS).
- Diagnosed patients of low back pain.
- Non-radicular low back pain.
- Quadratus Lumborum tightness by physical test i.e. side bending test.
Who cannot join
- Pregnant females.
- Lumbar radiculopathy.
- Any spinal pathology i.e. infectious disease and fracture.
- Any congenital deformity of spine, upper and lower extremities.
- Systemic illnesses i.e. cardiovascular disorders, respiratory disorders etc.
- History of surgery of hip, pelvis, lumbar spine, disc herniation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore teaching Hospital
Lahore, Punjab Province, 53700
About this study
Official title: Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
•Null hypothesis: There is no difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
•Alternative hypothesis: There is difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
Read the detailed description
The purpose of the study is to compare the effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain on Pain, Range of Motion, Quality of Life and Functional Disability.
The study procedure will be explained to the patients and informed written consent will be obtained from those patients who will be willing to participate in the study. Quadratus Lumborum tightness will be assessed using side bending test.
Those fulfilling the requirement of inclusion criteria will be indiscriminately separated into 2 groups. NPRS, Oswestry Disability Index, SF-20 and goniometer will be used to collect data.
Total 68 participants will be recruited in the study. Routine Physical therapy will be provided to group A. Reciprocal inhibition Muscle Energy Technique on quadratus lumborum along with Routine Physical Therapy will be performed on group B.
Both group will receive interventions three sessions in a week for 4 consecutive weeks.
Assessment of Pain, Range of motion, Quality of Life and Functional Disability will be assessed by using goniometer, NPRS, Oswestry Disability Index and SF-20 Questionnaire respectively for both groups at the baseline, end of 6th session (2nd week) and end of 12th session (4th week) and follow up will be obtained after 1 month (8th week).
- Conditions
- Chronic Low-back Pain
- Being tested
- Routine Physical Therapy, Muscle Energy Technique
- Keywords
- Low back pain, Lumbar pain, Backache, Muscle Energy Technique, Quadratus Lumborum
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical TherapyOther
Also called Conventional Physical Therapy
Routine physical therapy will be provided to group A for 25 minutes thrice a week for 4 weeks.
Muscle Energy TechniqueOther
Muscle Energy technique along with Routine physical therapy will be provided to group B for40 minutes thrice a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Routine Physical Therapy group | Active comparator | Routine physical therapy group includes thermotherapy for 10 mins, transcutaneous electrical nerve stimulations for 10 mins. Exercises such as: Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions.
Treatment duration will be 25 minutes. Receives: Other: Routine Physical Therapy |
| Experimental group | Experimental | Experimental group includes 6-7 repetitions of Muscle energy technique on Quadratus Lumborum muscle and Routine physical therapy, i.e Thermotherapy, transcutaneous electrical nerve stimulations, Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions.
Treatment duration will be 40 minutes. Receives: Other: Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be assessed by Numeric pain rating scale
Pain will be measured using 11 point Numeric Pain rating scale (NPRS). 0 score represents no pain, 1-3 score represents mild pain, 4-6 represents moderate pain and 7-10 represents severe pain.
Measured: 1 minute
Range of Motion will be assessed by Universal Goniometer
Lumbar flexion, extension and side bending range of motion will be measured using Universal Goniometer. Normal lumbar flexion range is 60 degrees, extension range is 25 degrees, and right and left side bending range is 25 degrees.
Measured: 2 minutes
Quality of life will be assessed by Medical outcomes study: 20 item Short form survey instrument
The SF-20 measure contains three dimensions about function (physical, social and role) and well-being (mental health, health perception and pain). score between 75- 100 leveled as good quality of life of low back pain patients, Average QOL marked when QOL score between 50-74, and QOL score between 0-49 leveled as poor QOL.
Measured: 8 minutes
Functional Disability will be assessed by Oswestry Low Back Pain Disability Index
Oswestry disability index is a validated, 10-point patient-reported outcome questionnaire. • 0% to 20% is scored as minimal disability. • 21%-40% is scored as moderate disability. • 41%-60% is scored as severe disability. • 61%-80% is scored as crippled. • 81%-100% scored as bedbound patients.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start27 Oct 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 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.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadia Ehsan, University of Lahore
- Investigators
- M Waqar Afzal, Mphil-MSK, Study chair, University of LahoreSyed Asadullah Arslan, Ph.D. PT, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174520
- Sponsor's protocol ID
- MSPTM02193012
- Status last verified
- Aug 2022
- First submitted
- 13 Dec 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05174520
- Acronym / sponsor ID
- MSPTM02193012
- Conditions
- Chronic Low-back Pain
- Keywords
- Low back pain, Lumbar pain, Backache, Muscle Energy Technique, Quadratus Lumborum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 30 Dec 2021 (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.
•Null hypothesis: There is no difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
•Alternative hypothesis: There is difference in effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
Detailed description
The purpose of the study is to compare the effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain on Pain, Range of Motion, Quality of Life and Functional Disability.
The study procedure will be explained to the patients and informed written consent will be obtained from those patients who will be willing to participate in the study. Quadratus Lumborum tightness will be assessed using side bending test.
Those fulfilling the requirement of inclusion criteria will be indiscriminately separated into 2 groups. NPRS, Oswestry Disability Index, SF-20 and goniometer will be used to collect data.
Total 68 participants will be recruited in the study. Routine Physical therapy will be provided to group A. Reciprocal inhibition Muscle Energy Technique on quadratus lumborum along with Routine Physical Therapy will be performed on group B.
Both group will receive interventions three sessions in a week for 4 consecutive weeks.
Assessment of Pain, Range of motion, Quality of Life and Functional Disability will be assessed by using goniometer, NPRS, Oswestry Disability Index and SF-20 Questionnaire respectively for both groups at the baseline, end of 6th session (2nd week) and end of 12th session (4th week) and follow up will be obtained after 1 month (8th week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Physical Therapy group | Active comparator | Other: Routine Physical TherapyRoutine physical therapy group includes thermotherapy for 10 mins, transcutaneous electrical nerve stimulations for 10 mins. Exercises such as: Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions. Treatment duration will be 25 minutes. |
| Experimental group | Experimental | Other: Muscle Energy TechniqueExperimental group includes 6-7 repetitions of Muscle energy technique on Quadratus Lumborum muscle and Routine physical therapy, i.e Thermotherapy, transcutaneous electrical nerve stimulations, Pelvic tilts, bridging exercise, William flexion exercises and stretching will be performed for 7-10 repetitions. Treatment duration will be 40 minutes. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders of age 30 to 55 year.
- Patients with pain for at least three months or more (chronic stage).
- Patients having score of at least 3 on 0-10 points(NPRS).
- Diagnosed patients of low back pain.
- Non-radicular low back pain.
Key exclusion criteria (6 listed)
- Pregnant females.
- Lumbar radiculopathy.
- Any spinal pathology i.e. infectious disease and fracture.
- Any congenital deformity of spine, upper and lower extremities.
- Systemic illnesses i.e. cardiovascular disorders, respiratory disorders etc.
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 |
|---|---|---|
| Routine Physical TherapyAlso: Conventional Physical TherapyRoutine physical therapy will be provided to group A for 25 minutes thrice a week for 4 weeks. | Other | Routine Physical Therapy group |
| Muscle Energy TechniqueMuscle Energy technique along with Routine physical therapy will be provided to group B for40 minutes thrice a week for 4 weeks. | Other | Experimental group |
Primary outcome
Pain will be assessed by Numeric pain rating scale
Time frame: 1 minute
Pain will be measured using 11 point Numeric Pain rating scale (NPRS). 0 score represents no pain, 1-3 score represents mild pain, 4-6 represents moderate pain and 7-10 represents severe pain.
Range of Motion will be assessed by Universal Goniometer
Time frame: 2 minutes
Lumbar flexion, extension and side bending range of motion will be measured using Universal Goniometer. Normal lumbar flexion range is 60 degrees, extension range is 25 degrees, and right and left side bending range is 25 degrees.
Quality of life will be assessed by Medical outcomes study: 20 item Short form survey instrument
Time frame: 8 minutes
The SF-20 measure contains three dimensions about function (physical, social and role) and well-being (mental health, health perception and pain). score between 75- 100 leveled as good quality of life of low back pain patients, Average QOL marked when QOL score between 50-74, and QOL score between 0-49 leveled as poor QOL.
Functional Disability will be assessed by Oswestry Low Back Pain Disability Index
Time frame: 5 minutes
Oswestry disability index is a validated, 10-point patient-reported outcome questionnaire. • 0% to 20% is scored as minimal disability. • 21%-40% is scored as moderate disability. • 41%-60% is scored as severe disability. • 61%-80% is scored as crippled. • 81%-100% scored as bedbound patients.
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 31 Aug 2022.
- Individual participant dataSharing planned: No
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Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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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.
M Waqar Afzal, Mphil-MSK study chair
University of Lahore
Syed Asadullah Arslan, Ph.D. PT study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physical Therapy and Muscle Energy Technique in people with Chronic Low-back Pain, run by University of Lahore at 1 site in Pakistan.
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 6 inclusion and 6 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 31 Aug 2022. 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 Pakistan. 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?
Pain will be assessed by Numeric pain rating scale (time frame: 1 minute). 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 31 Aug 2022.