Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT07082660
Status:
COMPLETED
Last Update Posted:
2025-07-24
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tecar Therapy in Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were masked to their group assignments throughout the intervention period. Both groups received treatment in a similar clinical environment, and the application of TECAR therapy was performed using identical procedures and equipment setup to prevent participants from discerning their allocation. The physiotherapist administering the intervention was aware of group assignments, but outcome assessments were standardized to minimize bias.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to two parallel groups receiving either TECAR + lumbar stabilization or lumbar stabilization only.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lumbar functionality', 'timeFrame': 'Baseline - 4 weeks', 'description': 'The Oswestry Disability Index (ODI), validated Turkish version, will be used to assess disability related to low back pain. The scale consists of 10 items, each scored from 0 to 5, with a total maximum score of 50. The total score is converted into a percentage using the formula: (total obtained score / maximum possible score) × 100. Scores range from 0% to 100%, where higher scores indicate greater disability. Interpretation categories are as follows: 0%-20% indicates minimal disability; 21%-40% indicates moderate disability; 41%-60% indicates severe disability; 61%-80% indicates crippled; and 81%-100% indicates bed-bound status or possible symptom exaggeration.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline - 4 weeks', 'description': "The Visual Analog Scale (VAS) will be used to assess pain intensity. It consists of a 10-centimeter horizontal line representing a continuum from 'no pain' (0) to 'worst imaginable pain' (10). Participants are asked to mark a point on the line that corresponds to the intensity of their pain. The distance in centimeters from the 'no pain' anchor to the participant's mark is measured and recorded as the VAS score. Scores range from 0 to 10, with higher scores indicating greater pain severity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbal disk herniation', 'Capasitive and resistive electric transfer therapy', 'exercise training'], 'conditions': ['Lumbal Disc Herniation', 'Capacitive and Resistive Electric Transfer Therapy', 'Exercise Training']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates the effects of Tecar therapy on pain intensity and functional status in patients with lumbar disc herniation. The intervention group received Tecar therapy combined with conventional physiotherapy, while the control group received only conventional physiotherapy. Outcome measures include pain intensity, lumbar mobility, and functional disability. The study aims to determine whether Tecar therapy provides additional benefits compared to standard care in the early rehabilitation of individuals with lumbar disc herniation.', 'detailedDescription': 'Background Lumbar disc herniation (LDH) is a prevalent musculoskeletal condition that can significantly impair quality of life due to pain and functional limitations. Rehabilitation strategies often include lumbar stabilization exercises, and adjunct electrotherapies such as capacitive-resistive diathermy (TECAR) have gained interest for their potential therapeutic effects.\n\nPurpose This randomized controlled trial aims to evaluate the effects of adding high-frequency capacitive-resistive diathermic current (TECAR) therapy to lumbar stabilization exercises, compared to lumbar stabilization exercises alone, on pain intensity, functional status, and lumbar range of motion in individuals with chronic LDH.\n\nMethods\n\nThirty participants with chronic LDH (duration \\>6 months) and no neurological deficits will be randomly assigned to one of two intervention groups:\n\nTECAR + Exercise Group (TEG, n=15): Participants will receive 12 sessions of TECAR therapy (20 minutes, 3 sessions per week) in combination with lumbar stabilization exercises over 4 weeks.\n\nExercise Group (EG, n=15): Participants will receive only lumbar stabilization exercises with the same frequency and duration.\n\nOutcome measures will include:\n\nPain intensity (Visual Analog Scale - VAS)\n\nFunctional status (Oswestry Disability Index - ODI)\n\nLumbar range of motion (goniometry)\n\nAll evaluations will be performed pre- and post-intervention by a physiotherapist who is blinded to group allocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 20-60 years\n* diagnosed with low back pain\n* pain localized between L1 and L5\n* having low back pain lasting for more than 3 months \\[24\\].\n\nExclusion Criteria:\n\n* having sensory disturbances\n* muscle weakness, or reflex loss identified during motor, sensory, or reflex examinations\n* history of prior lumbal spine surgery or vertebral fractures\n* presence of electronic medical devices such as pacemakers or other implants contraindicated for electrical stimulation or high-frequency diathermy therapy\n* patients officially registered as disabled or receiving social benefits due to low back pain, severe osteoporosis, osteomalacia, malignancy, infectious diseases, or systemic musculoskeletal or rheumatological disorders,\n* pregnancy,\n* cardiovascular conditions preventing exercise, or viscerogenic causes of low back pain'}, 'identificationModule': {'nctId': 'NCT07082660', 'acronym': 'LDH-TECAR', 'briefTitle': 'Tecar Therapy in Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Atlas University'}, 'officialTitle': 'A Randomized Controlled Trial On Lumbal Disc Herniation Using Tecar Therapy: Effects On Pain And Functionality', 'orgStudyIdInfo': {'id': 'ETTBI-LDH-2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TECAR Therapy Combined with Lumbal Stabilization Exercises', 'description': 'Participants in this group will receive high-frequency capacitive-resistive diathermic current (TECAR) therapy (20 minutes per session, 3 sessions/week for 4 weeks) in addition to a lumbal stabilization exercise program (12 sessions total).', 'interventionNames': ['Device: High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lumbal Stabilization Exercises Only', 'description': 'Participants in this group will receive only the lumbal stabilization exercise program, 3 sessions/week for 4 weeks (12 sessions total), with no TECAR therapy applied.', 'interventionNames': ['Behavioral: Lumbal Stabilization Exercise Program']}], 'interventions': [{'name': 'High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR)', 'type': 'DEVICE', 'description': '20 minutes per session, 3 times per week for 4 weeks', 'armGroupLabels': ['TECAR Therapy Combined with Lumbal Stabilization Exercises']}, {'name': 'Lumbal Stabilization Exercise Program', 'type': 'BEHAVIORAL', 'description': '3 sessions per week for 4 weeks, each session includes core stabilization and lumbar control exercises (12 sessions total).', 'armGroupLabels': ['Lumbal Stabilization Exercises Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34403', 'city': 'Istanbul', 'state': 'Kagıthane', 'country': 'Turkey (Türkiye)', 'facility': 'Atlas University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The IPD and supporting documents will be available beginning 6 months after publication of the primary results and will be accessible for a period of 3 years.', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie the results reported in the article (after deidentification) will be shared with other researchers upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Şebnem Nur Alkan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Physiotherapy, Atlas University', 'investigatorFullName': 'Şebnem Nur Alkan', 'investigatorAffiliation': 'Atlas University'}}}}