- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389070
Positional Release With/Without Exercise for Chronic LBP (LBP)
Evaluating the Effectiveness of Positional Release Technique With and Without Therapeutic Exercises for Chronic Low Back Pain Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background & Rationale:
Chronic low back pain (CLBP) is complex and prone to recurrence, making its management difficult. Clinicians often use passive manual therapies like the Positional Release Technique (PRT) to reduce pain. However, evidence suggests that passive treatments alone may not provide long-term relief unless combined with active interventions. Therapeutic exercise (TE) is a fundamental active approach that targets core deficits in strength and motor control. The key question is whether adding TE to PRT offers a significant advantage over PRT used in isolation.
Aim:
This study aimed to directly compare the clinical effectiveness of a combined treatment (PRT + TE) versus PRT alone in managing CLBP, with the hypothesis that the combined approach would be superior.
Methodology:
A randomized controlled trial was conducted with 60 participants diagnosed with CLBP (pain duration ≥3 months), aged 20-65. They were recruited from a single physiotherapy center. Participants with specific spinal pathologies (e.g., fractures, disc abnormalities) were excluded. They were randomly divided into two groups:
Group A (Experimental): Received PRT combined with a structured Therapeutic Exercise program.
Group B (Control): Received PRT alone.
Outcome Measures:
Effectiveness was assessed using standardized tools measured before and after the treatment period:
Pain Intensity: Visual Analogue Scale (VAS). Functional Disability: Roland-Morris Questionnaire (RMQ). Muscular Performance: A curl-up test for abdominal endurance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Bank
-
Bethlehem, West Bank, Palestinian Territories, 3600700
- Palestine Ahliya University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged 20-65 years.
- Clinical diagnosis of chronic low back pain (CLBP).
- Positive Faber (Patrick's) test.
- Positive Slump test.
- A pain intensity score of ≥3 on the Visual Analogue Scale (VAS).
- Symptoms presenting with or without referred leg pain.
Exclusion Criteria:
- Diagnosis of spondylolisthesis, disc disease, osteoporosis, or other significant bone disease.
- History of vertebral fractures.
- History of spinal surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: arm 1- Group A (PRT): Positional Release Technique with exercises
Group A (n=30) underwent a 12-session program over four weeks.
Each 40-minute session combined two 30-minute positional release procedures with three 10-minute therapeutic exercise modules.
|
Postional release technique with exercises.
|
|
Experimental: arm 2- Group A (PRT): Positional Release Technique without exercises
Group B received 12 treatment sessions over four weeks (three sessions/week), each consisting of two positional release procedures totaling 30 minutes.
|
Postional release technique without exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS
Time Frame: 4 weeks
|
A validated, single-item scale used to measure subjective pain intensity.
Patients mark a point on a 10-cm line anchored by "no pain" (0) and "worst pain imaginable" (10).
The score is the measured distance in cm/mm, providing a quantitative pain rating.
|
4 weeks
|
|
RMQ
Time Frame: 4 weeks
|
The Roland-Morris Disability Questionnaire (RMQ) is a widely used, self-administered, health status measure designed to assess physical function and disability specifically related to low back pain.
It consists of 24 yes/no statements derived from the Sickness Impact Profile, each describing a specific activity limitation due to back pain (e.g., "I walk more slowly because of my back").
The total score (0-24) is the sum of items marked "yes," with a higher score indicating greater disability.
It is valued for its brevity, ease of use, and responsiveness to clinical change.
|
4 weeks
|
|
Endurance
Time Frame: 4 weeks
|
An endurance test is a performance-based assessment that measures the ability of specific muscle groups (particularly the trunk stabilizers: back extensors, flexors, and lateral musculature) to maintain a submaximal contraction or a fixed posture against gravity over time.
Common examples used in low back pain research include the prone plank (trunk flexors), Sorensen/Biering-Sørensen test (back extensors), and side plank (lateral stabilizers).
The outcome is the time (in seconds) the position can be held until failure, providing an objective measure of muscular stamina.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- https://doi.org/10.1056/NEJMcp2032396
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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