Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:58 PM
Study NCT ID:
NCT07335718
Status:
RECRUITING
Last Update Posted:
2026-01-13
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Focused Radiofrequency (TECAR) Therapy on Pain, Disability, Function, and Quality of Life in Patients With Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-02', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-01-02', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Up to 1 month after the end of treatment', 'description': 'Zero indicates no pain at all, whereas ten represents the most severe pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': 'Up to 1 month after the end of treatment', 'description': 'The Oswestry Disability Index (ODI) is a standardized questionnaire designed to assess the degree of disability and functional impairment in individuals with lower back pain'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar Disc Herniation', 'TECAR Therapy', 'Pain'], 'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'Low back pain is a very common health problem in societies, regardless of the underlying cause. Its lifetime prevalence has been reported to be as high as 75-80%. Low back pain negatively affects the quality of life of affected individuals. In addition to diagnostic and treatment costs, it can lead to serious physical disability, resulting in loss of workforce and placing a substantial economic burden on countries. Many different factors play a role in the etiology of low back pain. According to etiology, it can be classified as idiopathic, mechanical, rheumatologic, metabolic, endocrine, infectious, neoplastic, neurologic/psychiatric disorders, and pain of visceral origin. The treatment of low back pain can be classified into medical treatment, physical therapy, percutaneous invasive interventions, and surgical intervention. TECAR therapy is also one of the treatment modalities routinely used in clinical practice. Our aim is to develop more effective physical therapy programs.', 'detailedDescription': 'The study is planned as a prospective, randomized, double-blind trial. According to power analysis, 54 patients will be included to achieve 95% power. Eligible participants will be women or men aged 20-60 years who are diagnosed with lumbar disc herniation, have low back pain lasting longer than 12 weeks, present to the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital as outpatients, and consent to participate in the study.\n\nAccording to the study criteria, initial evaluations will be performed by a single Physical Medicine and Rehabilitation physician. Demographic data of eligible patients, including age, sex, height, weight, occupation, and systemic diseases, will be recorded.\n\nPatients will be evaluated before treatment, immediately after treatment, and one month after the end of treatment using the following scales: Visual Analog Scale (VAS) for pain, Numeric Rating Scale (NRS), Quality of Life Scale (SF-36), Roland-Morris Disability Questionnaire, Oswestry Disability Index, Finger-to-Floor Distance Measurement, Beck Depression Inventory, and Lumbar Schober Test.\n\nPatients will be divided into two groups. The first group will receive a home exercise program including lumbar active range of motion exercises and lumbar isometric strengthening exercises, performed five times per week for three weeks according to the level of movement restriction and pain severity, along with TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.\n\nThe second group will receive the same home exercise program-including lumbar active range of motion exercises and lumbar isometric strengthening exercises-performed five times per week for three weeks according to the level of movement restriction and pain severity, along with sham TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to the outpatient clinic of the Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having low back pain lasting longer than 12 weeks\n\nHaving a diagnosis of lumbar disc herniation (bulging, protruded, or extruded)\n\nBeing able to comply with the exercise program\n\nWillingness to participate in the study Being between 20 and 60 years of age\n\nExclusion Criteria:\n\nBeing younger than 20 years or older than 60 years\n\nHaving a known and/or newly diagnosed malignancy\n\nPresence of cardiac implants such as a pacemaker\n\nHaving inflammatory low back pain\n\nHaving absolute spinal stenosis (anteroposterior diameter of the spinal canal \\< 10 mm and anteroposterior diameter of the lateral recess \\< 3 mm)\n\nHistory of surgery due to lumbar disc herniation, lumbar spinal stenosis, vertebral fracture, or similar conditions\n\nPresence of lumbar spondylolisthesis\n\nPatients with sequestered disc herniation\n\nPatients with polyneuropathy\n\nPatients with central pain following stroke\n\nPatients with neurological deficits\n\nHaving a diagnosed neurodegenerative disease\n\nHaving a systemic musculoskeletal disease\n\nPatients with acute deep vein thrombosis\n\nPregnancy\n\nPresence of infection at the skin surface where treatment will be applied\n\nUnexplained weight loss\n\nBladder and/or bowel incontinence\n\nHaving received physical therapy modalities or injections for low back pain within the last 1 month\n\nHaving cognitive impairment\n\nRefusal to participate in the study\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07335718', 'acronym': 'TECAR THERAPY', 'briefTitle': 'Evaluation of the Effectiveness of Focused Radiofrequency (TECAR) Therapy on Pain, Disability, Function, and Quality of Life in Patients With Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Evaluation of the Effectiveness of Focused Radiofrequency (TECAR) Therapy on Pain, Disability, Function, and Quality of Life in Patients With Lumbar Disc Herniation', 'orgStudyIdInfo': {'id': 'TABED 1-24-833'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TECAR Therapy', 'description': 'Patients with lumbar disc herniation', 'interventionNames': ['Device: TECAR THERAPY']}, {'label': 'sham TECAR Therapy', 'description': 'Patients with lumbar disc herniation', 'interventionNames': ['Device: TECAR Therapy']}], 'interventions': [{'name': 'TECAR THERAPY', 'type': 'DEVICE', 'description': 'TECAR therapy applied by a technician for 20 minutes per session, three days per week, for a total of six sessions', 'armGroupLabels': ['TECAR Therapy']}, {'name': 'TECAR Therapy', 'type': 'DEVICE', 'description': 'TECAR therapy is a new and effective treatment modality.', 'armGroupLabels': ['sham TECAR Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ankara bilkent city hospital ankara bilkent city hospital', 'role': 'CONTACT', 'email': 'ankarasehir@saglik.gov.tr', 'phone': '0312 552 60 00'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'cemre y yılmaz', 'role': 'CONTACT', 'email': 'saymazcemre@gmail.com', 'phone': '0312 552 60 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'I am undecided because the study is currently ongoing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'Cemre Saymaz', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}