NCT07389070

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 24, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

LBPPRTExercies

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    4 weeks

Study Arms (2)

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.

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.

Other: PRT Without exercises

Interventions

Postional release technique with exercises.

arm 1- Group A (PRT): Positional Release Technique with exercises

Postional release technique without exercises.

arm 2- Group A (PRT): Positional Release Technique without exercises

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Diagnosis of spondylolisthesis, disc disease, osteoporosis, or other significant bone disease.
  • History of vertebral fractures.
  • History of spinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palestine Ahliya University

Bethlehem, West Bank, 3600700, Palestinian Territories

Location

Related Publications (1)

  • https://doi.org/10.1056/NEJMcp2032396

    BACKGROUND

MeSH Terms

Interventions

Hypoxanthine PhosphoribosyltransferaseExercise

Intervention Hierarchy (Ancestors)

PentosyltransferasesGlycosyltransferasesTransferasesEnzymesEnzymes and CoenzymesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Azzam M. Alarab, Ph.D Assistant Professor Chairperson, Department of Medical Sciences - Master's Palestine Ahliya University

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 5, 2026

Study Start

June 1, 2024

Primary Completion

September 30, 2024

Study Completion

October 30, 2024

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations