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临床试验/NCT07389070
NCT07389070已完成不适用

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

Palestine Ahliya University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
VAS

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

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.

干预措施: PRT with exercises (Other)

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.

干预措施: PRT Without exercises (Other)

结局指标

主要结局

VAS

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Palestine Ahliya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Azzam Alarab

Azzam M. Alarab, Ph.D Assistant Professor Chairperson, Department of Medical Sciences - Master's Palestine Ahliya University

Palestine Ahliya University

研究点 (1)

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