Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-04-14 @ 12:32 AM
Study NCT ID:
NCT04521127
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dry Needling and Kinesio Taping in the Treatment of Myofascial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be aware of group distribution due to the nature of the taping and DN procedures. Therefore, the only outcome assessor will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three groups with a conventional therapy control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Pain Threshold (PPT) Measurement', 'timeFrame': 'two weeks', 'description': 'Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': 'two weeks', 'description': 'The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).'}, {'measure': 'Neck Disability Index', 'timeFrame': 'two weeks', 'description': 'Perceived disability of patients was assessed with 10-item item Neck Disability Index (NDI),which a modified from Oswestry Low Back Pain Disability Index to assess with a score range of 0 to 50.'}, {'measure': 'Global Perceived Effect Scale', 'timeFrame': 'two weeks', 'description': 'Change in the perception of the symptoms after the treatment was measured by a Global Perceived Effect Scale. Patients were asked to rate change between 1 completely recovered, 4 unchanged, 7 vastly worse on a horizontal likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Taping', 'Pain', 'Trigger Point', 'Dry needling'], 'conditions': ['Myofascial Pain Syndrome of Neck']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effectiveness of kinesio tape and dry needling in the treatment of myofascial pain syndrome of the trapezius muscle.', 'detailedDescription': 'Myofascial pain syndrome (MPS) is a common problem with manifesting itself such as trigger points, taut bands, range of motion limitations and pain. One of the most common place for MPS is neck region and trapezius muscle is the common cause of these symptoms and 9 different trigger point location has been identified on trapezius muscle. Myofascial trigger points, characterized by hypersensitive nodules, can be palpated in stretched bands in the affected muscles. In order to eliminate trigger points fascial releasing, dry needling, kinesio taping and other physical therapy applications can be used.\n\nAlthough there are several studies investigating the effectiveness of Kinesio taping (KT) and Dry needling(DN) methods in MPS, it is controversial which one is superior to others.\n\nThe aim of this study is to compare the effects of exercise, KT, and DN methods on pain and disability in the treatment of upper trapezoidal muscle MPS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosis with MPS and having active myofascial trigger points on trapezius muscle\n\nExclusion Criteria:\n\n* Fibromyalgia\n* a history of myofascial trigger point injection\n* acute trauma\n* inflammatory joint or muscle disease\n* infection or malignancy on cervical region\n* neurological disorders\n* cervical radiculopathy or myelopathy\n* inadequate cooperation for the treatment\n* a history of neck surgery or spinal degeneration'}, 'identificationModule': {'nctId': 'NCT04521127', 'briefTitle': 'Dry Needling and Kinesio Taping in the Treatment of Myofascial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Comparison of Dry Needling and Kinesio Taping Methods in the Treatment of Myofascial Pain Syndrome', 'orgStudyIdInfo': {'id': 'Physical Med-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Kinesio Taping Group', 'description': 'Kinesio taping will be applied to trapezius muscle', 'interventionNames': ['Other: Kinesio Taping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dry needling Group', 'description': 'Dry needling will be applied to trigger point on trapezius muscle', 'interventionNames': ['Other: Dry needling']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group will not receive any additional intervention'}], 'interventions': [{'name': 'Kinesio Taping', 'type': 'OTHER', 'description': 'Taping will be performed on sitting position with contralateral lateral flexion and flexion of the neck, using muscle technique with I strip and stretching the head at the maximum level in order to benefit from the muscle release effect. Kinesio tape was applied directly on muscle with 0% stretching.', 'armGroupLabels': ['Kinesio Taping Group']}, {'name': 'Dry needling', 'type': 'OTHER', 'description': 'The trigger point on the taut band will be held with the thumb and forefinger from below and above. In the needling technique, a 0.25 \\* 25-mm with nickel handle, disposable sterile steel acupuncture needle will be used. The needle tip will be inserted perpendicularly into the subcutaneous tissue and inserted into the muscle until the trigger point in the taut band was found. The same point will be pinned 8-10 times with fast needle movements inside and out. Then the needle tip will pulled back so that it did not come out of the skin, and the bottom, top and sides of the first entered point were also pinned. This procedure was applied to all trigger points in the trapeze muscle.', 'armGroupLabels': ['Dry needling Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14100', 'city': 'Bolu', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Abant Izzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'Mustafa Fatih Yaşar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bolu Abant Izzet Baylsa University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ramazan KURUL', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}