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NCT Number: NCT07419958

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

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.

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Key information

Conditions

Progressive Relaxation Exercise Anxiety Disorders Bone Diseases Hernia Intervertebral Disc Displacement Kinesiophobia Mental Disorders Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 4400, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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
  • The participant takes a deep breath as taught previously.
  • The participant performs muscle contraction along with deep inspiration.
  • The participant then ends the contraction while exhaling through the mouth and relaxing.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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