Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:29 AM
Study NCT ID:
NCT07419958
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Relaxation Exercises on Fear of Movement, Pain, and Quality of Life in Lumbar Disc Herniation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Kinesiophobia Score', 'timeFrame': 'Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)', 'description': '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.'}, {'measure': 'Change in Pain Intensity (Visual Analog Scale)', 'timeFrame': 'Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)', 'description': '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.'}, {'measure': 'Change in Functional Disability Score (Oswestry Disability Index)', 'timeFrame': 'Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)', 'description': '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.'}, {'measure': 'Change in Quality of Life Score (Short Form-36 Health Survey)', 'timeFrame': 'Baseline and immediately after completion of the 15-session intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disc Herniation', 'Muscle Relaxation', 'Pain', 'Progressive Relaxation Exercise', 'Quality of Life'], 'conditions': ['Progressive Relaxation Exercise', 'Hernia', 'Pain', 'Kinesiophobia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Diagnosis of lumbar disc herniation confirmed by clinical evaluation and imaging findings\n* Presence of bulging or protruding lumbar disc herniation\n* Ability to participate in exercise sessions\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* History of lumbar spine surgery\n* Presence of rheumatologic disease\n* Neurological, orthopedic, or systemic conditions that may interfere with participation or assessment\n* Presence of spinal implants or metal instrumentation\n* Any medical condition preventing safe participation in exercise'}, 'identificationModule': {'nctId': 'NCT07419958', 'briefTitle': 'Effects of Relaxation Exercises on Fear of Movement, Pain, and Quality of Life in Lumbar Disc Herniation Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'Effects of Progressive Relaxation Exercises on Kinesiophobia, Pain, and Quality of Life in Patients With Lumbar Disc Herniation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024/157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients in the control group were asked to return to their routine activities.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'progressive relaxation exercise group', 'description': '* The exercises were performed under the supervision of a physiotherapist by using a program developed by Dr. Jonathon Smith and verbal instructions.\n* The patients were asked to wear comfortable clothes and take off their shoes during the session.\n* 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.\n* 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\n\n 1. The participant takes a deep breath as taught previously.\n 2. The participant performs muscle contraction along with deep inspiration.\n 3. The participant then ends the contraction while exhaling through the mouth and relaxing.', 'interventionNames': ['Other: progressive relaxation exercise']}], 'interventions': [{'name': 'progressive relaxation exercise', 'type': 'OTHER', 'description': '* The exercises were performed under the supervision of a physiotherapist by using a program developed by Dr. Jonathon Smith and verbal instructions .\n* The patients were asked to wear comfortable clothes and take off their shoes during the session.\n* 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.\n* 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\n\n 1. The participant takes a deep breath as taught previously.\n 2. The participant performs muscle contraction along with deep inspiration.\n 3. The participant then ends the contraction while exhaling through the mouth and relaxing.', 'armGroupLabels': ['progressive relaxation exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4400', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu University', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Ilker Demir, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University, Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'İlker DEMİR', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}