Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 5:48 PM
Study NCT ID:
NCT06959394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis in Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D015612', 'term': 'Phonophoresis'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain severity', 'timeFrame': 'Baseline and after 2 weeks intervation', 'description': 'Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'functional state', 'timeFrame': 'Baseline and after 2 weeks intervation', 'description': 'Oswestry Disability Index'}, {'measure': 'Flexibility', 'timeFrame': 'Baseline and after 2 weeks intervation', 'description': 'Sit and Reach Test'}, {'measure': 'range of motion of the joint', 'timeFrame': 'Baseline and after 2 weeks intervation', 'description': 'Goniometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of therapeutic ultrasound and phonophoresis applications on pain, range of motion, flexibility and functional capacity in patients with chronic low back pain. The study is planned as the first scientific study comparing the effectiveness of these two physiotherapy methods in the treatment of chronic low back pain. It is aimed to make national and international publications with the data obtained at the end of the study.\n\nThe study will be conducted in a randomised single-blind, placebo-controlled design. 60 patients aged 18-30 years with chronic low back pain will be divided into 3 groups: therapeutic ultrasound (US) application, phonophoresis application and placebo US group. In addition to ultrasound and phonophoresis, TENS, infrared and low back exercises will be applied to all groups as treatment. Pain intensity (VAS), functional status (Oswestry disability index), flexibility (Sit-to-Sit test) and range of motion (goniometric measurements) will be assessed throughout the treatment period.\n\nThe study aims to make an important contribution from a clinical and economic point of view, given the increasing prevalence of low back pain worldwide and the need for treatment. The findings may guide the development of future treatment modalities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals with low back pain for more than 3 months and pain intensity more than 5 according to VAS will be included in the study\n\nExclusion Criteria:\n\npatients who have undergone surgical operations'}, 'identificationModule': {'nctId': 'NCT06959394', 'briefTitle': 'Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis in Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'KTO Karatay University'}, 'officialTitle': 'Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis Applications in Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'KaratayMST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'US', 'description': 'Participants will be treated with 1.5 W/cm2, 6 min (transmitting agent aquasonic gel) ultrasound.', 'interventionNames': ['Other: Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Phonophoresis', 'interventionNames': ['Other: Phonophoresis']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ultrasound', 'type': 'OTHER', 'description': 'Participants will receive ultrasound at 1.5 W/cm2 for 6 minutes (transmitter agent aquasonic gel) 5 sessions per week for 2 weeks.', 'armGroupLabels': ['US']}, {'name': 'Phonophoresis', 'type': 'OTHER', 'description': 'Participants will receive ultrasound with 1.5 W/cm2, 6 min (transmitter diclofenac gel) for 5 sessions per week for 2 weeks.', 'armGroupLabels': ['Phonophoresis']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive 0 W/cm2, 6 min ultrasound, 5 sessions per week for 2 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mustafa savas torlak, associate professor doctor', 'role': 'CONTACT', 'email': 'mustafa.savas.torlak@karatay.edu.tr', 'phone': '+905373660138'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KTO Karatay University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle invastigator', 'investigatorFullName': 'Mustafa Savaş Torlak', 'investigatorAffiliation': 'KTO Karatay University'}}}}