跳至主要内容
临床试验/NCT07419958
NCT07419958已完成不适用

Effects of Progressive Relaxation Exercises on Kinesiophobia, Pain, and Quality of Life in Patients With Lumbar Disc Herniation: A Randomized Controlled Trial

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年12月1日最近更新:
适应症
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
96
试验地点
1
主要终点
Change in Kinesiophobia Score

研究概览

简要总结

This study evaluates whether progressive relaxation exercises can reduce fear of movement, pain, and improve quality of life in patients with lumbar disc herniation. Participants are randomly assigned to either a control group receiving standard care or an intervention group performing supervised relaxation exercises in addition to standard care. The exercise program is conducted three times per week for 15 sessions. Outcomes are measured before and after the intervention using validated scales assessing kinesiophobia, pain intensity, disability, and quality of life. The goal is to determine whether adding relaxation exercises provides additional benefits for patients with lumbar disc herniation.

详细描述

Lumbar disc herniation is a common musculoskeletal condition that can cause pain, functional limitation, and fear of movement, which may negatively affect daily activities and quality of life. Psychological factors such as kinesiophobia can contribute to disability and may interfere with rehabilitation outcomes. Relaxation-based approaches are noninvasive interventions that may help reduce muscle tension, pain perception, and movement-related fear.

This randomized controlled study investigates the effects of progressive relaxation exercises in patients diagnosed with lumbar disc herniation. Participants are assigned to either a control group receiving standard care or an intervention group receiving progressive relaxation exercises in addition to standard care. The exercise sessions are supervised and delivered over a structured treatment period. Outcome measures assess changes in fear of movement, pain severity, functional disability, and quality of life using validated assessment tools. The study aims to determine whether progressive relaxation exercises provide additional clinical benefit beyond standard care for this patient population. avoids repeating data entered elsewhere (dates, numbers, site names, etc.) is professional and registry-appropriate

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Age between 18 and 65 years
  • Diagnosis of lumbar disc herniation confirmed by clinical evaluation and imaging findings
  • Presence of bulging or protruding lumbar disc herniation
  • Ability to participate in exercise sessions
  • Willingness to participate and provide informed consent

排除标准

  • History of lumbar spine surgery
  • Presence of rheumatologic disease
  • Neurological, orthopedic, or systemic conditions that may interfere with participation or assessment
  • Presence of spinal implants or metal instrumentation
  • Any medical condition preventing safe participation in exercise

研究组 & 干预措施

Control

No Intervention

Patients in the control group were asked to return to their routine activities.

progressive relaxation exercise group

Active Comparator
  • The exercises were performed under the supervision of a physiotherapist by using a program developed by Dr. Jonathon Smith and verbal instructions.
  • The patients were asked to wear comfortable clothes and take off their shoes during the session.
  • Before the exercise, the patients were taught to breathe deeply through the nose and perform expression by positioning the lips as if making a "U" sound.
  • The exercises were performed in three sets for each session for the hip, abdominal, waist, back, chest, shoulder and neck muscle groups, as described below
  1. The participant takes a deep breath as taught previously.
  2. The participant performs muscle contraction along with deep inspiration.
  3. The participant then ends the contraction while exhaling through the mouth and relaxing.

干预措施: progressive relaxation exercise (Other)

结局指标

主要结局

Change in Kinesiophobia Score

时间窗: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)

The Tampa Scale for Kinesiophobia is a validated self-report questionnaire used to assess fear of movement related to pain or injury. Scores range from 17 to 68, with higher scores indicating greater fear of movement. Change is calculated as the difference between pre-intervention and post-intervention scores.

Change in Pain Intensity (Visual Analog Scale)

时间窗: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)

Pain intensity is assessed using the Visual Analog Scale (VAS), a validated measure consisting of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants rate their pain at rest and during movement. Change is calculated as the difference between pre-intervention and post-intervention scores.

Change in Functional Disability Score (Oswestry Disability Index)

时间窗: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)

Functional disability is assessed using the Oswestry Disability Index, a validated questionnaire that measures the degree of disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability. Change is calculated as the difference between pre-intervention and post-intervention scores.

Change in Quality of Life Score (Short Form-36 Health Survey)

时间窗: Baseline and immediately after completion of the 15-session intervention

Quality of life is assessed using the Short Form-36 Health Survey, a validated questionnaire that evaluates health-related quality of life across multiple domains. Scores range from 0 to 100 for each domain, with higher scores indicating better health status. Change is calculated as the difference between pre-intervention and post-intervention scores.

次要结局

未报告次要终点

研究者

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

İlker DEMİR

PhD

Hasan Kalyoncu University

研究点 (1)

Loading locations...

相似试验