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

NCT07419958 | Completed

• 1 other identifier: 2024/157
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Progressive Relaxation Exercise; Hernia; Pain; Kinesiophobia

Keywords

Disc Herniation; Muscle Relaxation; Pain; Progressive Relaxation Exercise; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Change in Kinesiophobia Score

  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)

  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)

  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)

  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

Study Arms (2)

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.

Other: progressive relaxation exercise

Interventions

progressive relaxation exercise OTHER

* 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.

progressive relaxation exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Inonu University

Malatya, 4400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hernia; Pain; Kinesiophobia; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Ilker Demir, PhD

  Inonu University, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Participants are randomly assigned to one of two parallel groups: a control group receiving standard care or an intervention group receiving progressive relaxation exercises in addition to standard care. Both groups are followed over the same study period, and outcomes are assessed before and after the intervention to compare changes between groups.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 19, 2026
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)