Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT04645095
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2020-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.', 'description': 'using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain'}, {'measure': 'Number of trigger points in the upper back region', 'timeFrame': 'Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.', 'description': 'using number'}, {'measure': 'Pressure pain', 'timeFrame': 'Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.', 'description': 'using algometer (kg/cm2)'}, {'measure': 'Neck joint range of motion', 'timeFrame': 'Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.', 'description': 'using double inclinometer'}, {'measure': 'Disability', 'timeFrame': 'Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.', 'description': 'using Modified Neck Disability Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myofascial Pain Syndromes', 'Transcutaneous Electrical Nerve Stimulation'], 'conditions': ['Myofascial Pain Syndromes']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to compare the effects of conventional, burst and modulated TENS primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in MAS treatment.', 'detailedDescription': 'Myofascial pain syndrome (MAS) is a regional pain syndrome characterized by trigger points detected by one or several muscle groups and reflected pain manifestation caused by palpation of these points. Transcutaneous electrical nerve stimulation (TENS) is a physical therapy modality that provides an analgesic effect by delivering a controlled low voltage electrical current to the nervous system through electrodes placed on the skin. Knowledge on how modulation parameters such as frequency, wave width and form alter TENS activity are limited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a diagnosis of myofascial pain syndrome according to the criteria defined by Travell and Simons\n\nExclusion Criteria:\n\n* The onset of symptoms is less than 3 months\n* Severe cervical disc hernia, radiculopathy or myelopathy\n* Stage 3-4 cervical degeneration\n* Tumoral, infectious, psychiatric, neurological, uncontrolled systemic disease\n* Cardiac pacemaker\n* Diagnosed with fibromyalgia syndrome\n* Kyphoscoliosis\n* Acute trauma history\n* Having had previous brain or shoulder surgery\n* Injections for MAS and / or physiotherapy programs in the last 3 months\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04645095', 'briefTitle': 'Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome?', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Which Type of Transcutaneous Electrical Nerve Stimulation is More Effective in Myofascial Pain Syndrome? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '10-427-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional TENS', 'description': 'Frequency:80 Hz, duration:100 μs', 'interventionNames': ['Device: Transcutaneous electrical nerve stimulation', 'Device: Hot pack']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Burst TENS', 'description': 'Frequency:100 Hz, fr mod: 0, 200 µs, 2 Bps Hz', 'interventionNames': ['Device: Transcutaneous electrical nerve stimulation', 'Device: Hot pack']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modulated TENS', 'description': 'Frequency:80 Hz, fr mod: 50%, Amplitude mode: 40%, duration: 200 µs', 'interventionNames': ['Device: Transcutaneous electrical nerve stimulation', 'Device: Hot pack']}], 'interventions': [{'name': 'Transcutaneous electrical nerve stimulation', 'type': 'DEVICE', 'otherNames': ['TENS'], 'description': 'All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.', 'armGroupLabels': ['Burst TENS', 'Conventional TENS', 'Modulated TENS']}, {'name': 'Hot pack', 'type': 'DEVICE', 'description': 'All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.', 'armGroupLabels': ['Burst TENS', 'Conventional TENS', 'Modulated TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Birkan Sonel Tur', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Birkan Sonel Tur, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor; MD', 'investigatorFullName': 'Birkan Sonel Tur', 'investigatorAffiliation': 'Ankara University'}}}}