- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928792
Effects Of Quadratus Lumborum Release on Respiratory Outcomes on Low Back Pain Patients
April 7, 2025 updated by: Riphah International University
The aim of this research is to check the effects of Quadratus Lumborum (QL) release on respiratory function and pain levels in individuals with chronic low back pain.
Randomized controlled trials done at Pakistan Railway General Hospital, Rawalpindi and Rawal General & Dental Hospital Islamabad.
The sample size was 36.
The subjects were divided into two groups, 18 subjects in the experimental group will receive muscle energy technique on quadratus lumborum along with conventional intervention for LBP and 18 in control group will only receive conventional intervention exercises for LBP.
Study duration was of 6 months.
Sampling technique applied was non probability connivance sampling technique.
Only 30-60 years both males and females diagnosed with mechanical low back pain persist at least >3 months.
Tools used in the study of Numeric Pain rating scale (Pain assessment).
Modified Oswestry Disability Index (m-ODI) (for ADLs in CLBP).
Inclinometer (for ranges of lumber spine).
Digital spirometer (for FEV1/FVC ratio).
Inches Tap (For Chest Expansion) & (For Quadratus lumborum length test).
Fatigue Severity Scale (FSS).
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The aim of this research is to check the effects of Quadratus Lumborum (QL) release on respiratory function and pain levels in individuals with chronic low back pain.
Randomized controlled trials done at Pakistan Railway General Hospital, Rawalpindi and Rawal General & Dental Hospital Islamabad.
The sample size was 36.
The subjects were divided into two groups, 18 subjects in the experimental group will receive muscle energy technique on quadratus lumborum along with conventional intervention for LBP and 18 in control group will only receive conventional intervention exercises for LBP.
Study duration was of 6 months.
Sampling technique applied was non probability connivance sampling technique.
Only 30-60 years both males and females diagnosed with mechanical low back pain persist at least >3 months.
Tools used in the study of Numeric Pain rating scale (Pain assessment).
Modified Oswestry Disability Index (m-ODI) (for ADLs in CLBP).
Inclinometer (for ranges of lumber spine).
Digital spirometer (for FEV1/FVC ratio).
Inches Tap (For Chest Expansion) & (For Quadratus lumborum length test).
Fatigue Severity Scale (FSS).
Study Type
Interventional
Enrollment (Actual)
36
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
-
-
Punjab
-
Islamabad, Punjab, Pakistan, 45550
- Rawal Institute of Rehabilitation Sciences
-
-
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
No
Description
Inclusion Criteria:
- Age 30-60 years.
- Both Genders: Male and Female.
- Diagnosed with mechanical low back pain persist at least >3 months.
- Self-evaluation of the breathing questionnaire, SEBQ >11.
- The patient exhibits decreased pulmonary functional volumes compared to the normal values, which include FEV, FVC,FEV₁/FVC
- The Quadratus Lumborum length test in side-lying inches indicates QL shortening.
- Patient with either unilateral or bilateral Quadratus lumborum tightness but intervention will be given on both sides.
- Numeric Pain Rating > 3/10.
Exclusion Criteria:
- Diagnosed chronic respiratory disease (e.g., asthma, COPD, bronchitis).
- Diagnosed non-mechanical low back pain (e.g., ankylosing spondylitis, tumors).
- Diagnosed lumbar spine surgery within the last 12 months.
- Diagnosed significant neurological deficits.
- Spinal injuries or other comorbidities.
- Infection, trauma, pregnancy, fracture, or fall.
- Unable to understand and follow the commands.
- Unwillingness to comply with the follow-up schedule.
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: Experimental: interventional group A: Muscle Energy Technique (MET)
10 min hot pack application, followed by MET on the Quadratus Lumborum (3 reps with a 7s hold).
Flexibility exercises include William flexion with b/L knee-to-chest stretches (10s hold, repeated 10 times) and static stretching of the hamstrings, gastrocnemius, and IT band (5 reps, 5s hold).
Strengthening exercises comprise isometric hip flexor activation (5 reps with a 15s hold), side planks (3 reps, 30s hold), and static side bending (5 reps, 10s hold).
The intervention will be performed once daily, consisting of 3 sets per session, continued for 4 weeks to enhance flexibility, core stability, and muscular balance, ultimately contributing to pain relief and improved functional mobility in CLBP patients
|
10-minute hot pack application, followed by MET on the Quadratus Lumborum (3 repetitions with a 7-second hold).
Flexibility exercises include William flexion with bilateral knee-to-chest stretches (10-second hold, repeated 10 times) and static stretching of the hamstrings, gastrocnemius, and iliotibial band (5 repetitions with a 5-second hold).
Strengthening exercises comprise isometric hip flexor activation (5 repetitions with a 15-second hold), side planks (3 repetitions with a 30-second hold), and static side bending (5 repetitions with a 10-second hold).
The intervention will be performed once daily, consisting of 3 sets per session, continued for 4 weeks to enhance flexibility, core stability, and muscular balance, ultimately contributing to pain relief and improved functional mobility in CLBP patients
|
|
Active Comparator: Control :interventional group B: (conventional intervention exercises)
10-minute hot pack application, followed by William flexion with bilateral knee-to-chest stretches (10s hold, reps 10 times).
Flexibility exercises consist of static stretching for the hamstrings, gastrocnemius, and iliotibial band (5 reps with a 5s hold).
Strengthening exercises include isometric hip flexor activation (5 reps with a 15s hold), side planks (3 reps with a 30s hold), and static side bending (5 reps with a 10s hold).
The protocol will be performed once daily, with 3 sets per session, continued for 4 weeks to improve flexibility, core stability, and pain management in CLBP patients.
|
10-minute hot pack application, followed by William flexion with bilateral knee-to-chest stretches (10-second hold, repeated 10 times).
Flexibility exercises consist of static stretching for the hamstrings, gastrocnemius, and iliotibial band (5 repetitions with a 5-second hold).
Strengthening exercises include isometric hip flexor activation (5 repetitions with a 15-second hold), side planks (3 repetitions with a 30-second hold), and static side bending (5 repetitions with a 10-second hold).
The protocol will be performed once daily, with 3 sets per session, continued for 4 weeks to improve flexibility, core stability, and pain management in CLBP patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain rating scale.
Time Frame: baseline measurement to 2 weeks
|
It is the tool to measure pain intensity It ranges from 0 to 10.
If the patient feels no pain, then 0 will be marked.
5 shows moderate pain and 10 will be marked if pain is most extreme ever felt by the patient.(10)
The patients were asked to mark the point they felt their pain accordingly
|
baseline measurement to 2 weeks
|
|
Digital spirometer.
Time Frame: baseline measurement to 2 weeks
|
Spirometry is a vital pulmonary function test used to assess lung health by measuring Peak Expiratory Flow (PEF)
|
baseline measurement to 2 weeks
|
|
Inches Tap (For Chest Expansion)
Time Frame: baseline measurement to 2 weeks after every session.
|
Chest expansion was measured in a standing position with elbows slightly flexed and hands on hips, using a non-stretchable inch tape at the 2nd intercostal space (ICS), 4th ICS, and xiphoid process.
Participants performed maximal deep inspiration and expiration, and the difference was recorded.
|
baseline measurement to 2 weeks after every session.
|
|
Fatigue Severity Scale (FSS)
Time Frame: baseline measurement to 2 weeks.
|
Unidimensional, nine-item self-reported questionnaire designed to assess the severity and impact of fatigue on daily functioning and quality of life over the past week.
Participants rate each item on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree), with higher scores indicating greater fatigue severity.
The total score is calculated by summing the individual item scores, resulting in a range from 9 to 63, with a score of ≥36 indicating significant fatigue.
|
baseline measurement to 2 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inclinometer for Lumbar Flexion.
Time Frame: baseline measurement to 2 weeks after every session
|
The inclinometer is a reliable and valid tool for measuring lumbar range of motion (ROM), including flexion, extension, and side bending.
To use the inclinometer, place one device on the T12 vertebra and another on the S1 vertebra while the patient stands in a neutral posture.
The patient then performs forward bending.
|
baseline measurement to 2 weeks after every session
|
|
Inclinometer for Lumbar Extension.
Time Frame: baseline measurement to 2 weeks after every session
|
The inclinometer is a reliable and valid tool for measuring lumbar range of motion (ROM), including flexion, extension, and side bending.
To use the inclinometer, place one device on the T12 vertebra and another on the S1 vertebra while the patient stands in a neutral posture.
The patient then performs lumbar extension.
|
baseline measurement to 2 weeks after every session
|
|
Inclinometer for Lumbar Side Bending (Rt)
Time Frame: baseline measurement to 2 weeks after every session
|
The inclinometer is a reliable and valid tool for measuring lumbar range of motion (ROM), including flexion, extension, and side bending.
To use the inclinometer, place one device on the T12 vertebra and another on the S1 vertebra while the patient stands in a neutral posture.
The patient then performs movements for right-side bending.
|
baseline measurement to 2 weeks after every session
|
|
Inclinometer for Lumbar Side Bending (Lt)
Time Frame: baseline measurement to 2 weeks after every session
|
The inclinometer is a reliable and valid tool for measuring lumbar range of motion (ROM), including flexion, extension, and side bending.
To use the inclinometer, place one device on the T12 vertebra and another on the S1 vertebra while the patient stands in a neutral posture.
The patient then performs left-side bending.
|
baseline measurement to 2 weeks after every session
|
|
Inclinometer for Lumbar Rotation (Rt)
Time Frame: baseline measurement to 2 weeks after every session
|
The inclinometer is a reliable and valid tool for measuring lumbar range of motion (ROM), including flexion, extension, and side bending.
To use the inclinometer, place one device on the T12 vertebra and another on the S1 vertebra while the patient stands in a neutral posture.
The patient then performs right rotation at lumbar
|
baseline measurement to 2 weeks after every session
|
|
Inclinometer for Lumbar Rotation (Lt)
Time Frame: baseline measurement to 2 weeks after every session
|
The inclinometer is a reliable and valid tool for measuring lumbar range of motion (ROM), including flexion, extension, and side bending.
To use the inclinometer, place one device on the T12 vertebra and another on the S1 vertebra while the patient stands in a neutral posture.The patient then performs Left rotation at lumbar.
|
baseline measurement to 2 weeks after every session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aisha Razzaq, PHD*, Riphah International 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)
January 7, 2025
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
January 31, 2026
Study Registration Dates
First Submitted
February 20, 2025
First Submitted That Met QC Criteria
April 7, 2025
First Posted (Actual)
April 15, 2025
Study Record Updates
Last Update Posted (Actual)
April 15, 2025
Last Update Submitted That Met QC Criteria
April 7, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/02134 Suleman
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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