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NCT Number: NCT07389070

Positional Release With/Without Exercise for Chronic LBP

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.

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Key information

Conditions

Back Disorder

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palestine Ahliya University

Bethlehem, West Bank, 3600700, Palestinian Territories

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRT with exercises

Other

Postional release technique with exercises.

PRT Without exercises

Other

Postional release technique without exercises.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Palestine Ahliya University

Other

Registry information

Official study title

Evaluating the Effectiveness of Positional Release Technique With and Without Therapeutic Exercises for Chronic Low Back Pain Management

Acronym: LBP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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