Effects of Relaxation Exercises on Fear of Movement, Pain, and Quality of Life in Lumbar Disc Herniation Patients

February 12, 2026 updated by: İlker DEMİR, Hasan Kalyoncu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients in the control group were asked to return to their routine activities.
Active Comparator: progressive relaxation exercise group
  • 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.
Other: progressive relaxation exercise
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Kinesiophobia Score
Time Frame: 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.
Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Change in Pain Intensity (Visual Analog Scale)
Time Frame: 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.
Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Change in Functional Disability Score (Oswestry Disability Index)
Time Frame: 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.
Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Change in Quality of Life Score (Short Form-36 Health Survey)
Time Frame: 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.
Baseline and immediately after completion of the 15-session intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Investigators

  • Principal Investigator: Ilker Demir, PhD, Inonu University, Faculty of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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