Back DisorderLBPNCT07389070
Positional Release With/Without Exercise for Chronic LBP
A study testing PRT with exercises and PRT Without exercises in people with Back Disorder, run by Palestine Ahliya University at 1 site in Palestinian Territories.
Trial summary
Chronic low back pain (CLBP) presents a significant therapeutic challenge due to its multifactorial nature and high recurrence rate. While manual therapy techniques like Positional Release Technique (PRT) are commonly employed to modulate pain and improve tissue function, there is a growing consensus in rehabilitation… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Disorder
- What is being tested?
- PRT with exercises and PRT Without exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Jun 2024to 30 Oct 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of spondylolisthesis, disc disease, osteoporosis, or other significant bone disease.
- History of vertebral fractures.
- History of spinal surgery.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Palestine Ahliya University
Bethlehem, West Bank, 3600700
About this study
Official title: Evaluating the Effectiveness of Positional Release Technique With and Without Therapeutic Exercises for Chronic Low Back Pain Management
Chronic low back pain (CLBP) presents a significant therapeutic challenge due to its multifactorial nature and high recurrence rate. While manual therapy techniques like Positional Release Technique (PRT) are commonly employed to modulate pain and improve tissue function, there is a growing consensus in rehabilitation that their effects may be transient if not coupled with active strategies to address underlying impairments. Therapeutic exercises (TE) form a cornerstone of CLBP management by aiming to restore strength, endurance, and neuromuscular control. However, the specific additive benefit of combining a passive, indirect technique like PRT with a structured TE program remains an area for empirical investigation. This study, therefore, sought to compare the clinical effectiveness of an integrated approach using PRT alongside TE against the application of PRT alone, hypothesizing that the combined intervention. would yield superior outcomes in pain reduction and functional improvement for individuals with CLBP.
Read the 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.
- Conditions
- Back Disorder
- Being tested
- PRT with exercises, PRT Without exercises
- Keywords
- LBP, PRT, Exercies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT with exercisesOther
Postional release technique with exercises.
PRT Without exercisesOther
Postional release technique without exercises.
| Study group | Role | What they receive |
|---|---|---|
| arm 1- Group A (PRT): Positional Release Technique with exercises | Experimental | 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. Receives: Other: PRT with exercises |
| arm 2- Group A (PRT): Positional Release Technique without exercises | Experimental | Group B received 12 treatment sessions over four weeks (three sessions/week), each consisting of two positional release procedures totaling 30 minutes. Receives: Other: PRT Without exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
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.
Measured: 4 weeks
RMQ
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.
Measured: 4 weeks
Endurance
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.
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 posted5 Feb 2026
- Study start1 Jun 2024
- Primary completion30 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back DisorderStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palestine Ahliya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azzam Alarab, Palestine Ahliya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389070
- Sponsor's protocol ID
- PAU
- Acronym
- LBP
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
https://doi.org/10.1056/NEJMcp2032396
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Positional Release Technique With and Without Therapeutic Exercises for Chronic Low Back Pain Management
- ClinicalTrials.gov ID
- NCT07389070
- Acronym / sponsor ID
- LBP / PAU
- Conditions
- Back Disorder
- Keywords
- LBP, PRT, Exercies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Palestine Ahliya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 5 Feb 2026 (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.
Chronic low back pain (CLBP) presents a significant therapeutic challenge due to its multifactorial nature and high recurrence rate. While manual therapy techniques like Positional Release Technique (PRT) are commonly employed to modulate pain and improve tissue function, there is a growing consensus in rehabilitation that their effects may be transient if not coupled with active strategies to address underlying impairments. Therapeutic exercises (TE) form a cornerstone of CLBP management by aiming to restore strength, endurance, and neuromuscular control. However, the specific additive benefit of combining a passive, indirect technique like PRT with a structured TE program remains an area for empirical investigation. This study, therefore, sought to compare the clinical effectiveness of an integrated approach using PRT alongside TE against the application of PRT alone, hypothesizing that the combined intervention. would yield superior outcomes in pain reduction and functional improvement for individuals with CLBP.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1- Group A (PRT): Positional Release Technique with exercises | Experimental | Other: PRT with exercisesGroup 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. |
| arm 2- Group A (PRT): Positional Release Technique without exercises | Experimental | Other: PRT Without exercisesGroup B received 12 treatment sessions over four weeks (three sessions/week), each consisting of two positional release procedures totaling 30 minutes. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- Diagnosis of spondylolisthesis, disc disease, osteoporosis, or other significant bone disease.
- History of vertebral fractures.
- History of spinal surgery.
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 |
|---|---|---|
| PRT with exercisesPostional release technique with exercises. | Other | arm 1- Group A (PRT): Positional Release Technique with exercises |
| PRT Without exercisesPostional release technique without exercises. | Other | arm 2- Group A (PRT): Positional Release Technique without exercises |
Primary outcome
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.
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.
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.
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 5 Feb 2026.
- Backgroundhttps://doi.org/10.1056/NEJMcp2032396
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRT with exercises and PRT Without exercises in people with Back Disorder, run by Palestine Ahliya University at 1 site in Palestinian Territories.
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 3 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 5 Feb 2026. 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 Palestinian Territories. 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?
VAS (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07389070, which also lists 1 linked publication.
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 5 Feb 2026.