Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07490366
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-18', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.', 'description': '0-10 scale. Higher scores represent more severe pain.'}, {'measure': 'Cervical Range of Motion', 'timeFrame': 'before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.', 'description': 'Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees.'}, {'measure': 'Neck Disability Index (NDI)', 'timeFrame': 'before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.', 'description': 'The Neck Disability Index (NDI) is a widely used self-report questionnaire that measures functional disability associated with neck pain. It consists of 10 items scored from 0 to 5, covering pain intensity and daily activities. Higher scores indicate greater disability. The NDI is commonly used in clinical practice and research to assess baseline status and monitor treatment outcomes.'}, {'measure': 'Pressure Pain Threshold (PPT)', 'timeFrame': 'before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.', 'description': 'Pressure Pain Threshold (PPT) is a quantitative measure of pain sensitivity assessed using a pressure algometer. It represents the minimum amount of pressure that evokes pain. PPT is widely used in clinical and research settings to evaluate mechanical pain sensitivity, detect hyperalgesia, and monitor treatment effects. Lower PPT values indicate increased pain sensitivity, while higher values reflect reduced sensitivity.'}], 'secondaryOutcomes': [{'measure': '12-Item Short Form Survey (SF-12)', 'timeFrame': 'before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.', 'description': 'The 12-Item Short Form Survey (SF-12) is a brief, validated questionnaire used to assess overall health-related quality of life. It measures physical and mental health through 12 questions derived from the SF-36. The survey generates two main scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better health status. The SF-12 is widely used in clinical practice and research due to its brevity, reliability, and ability to capture general functional health.'}, {'measure': 'Central Sensitisation Inventory', 'timeFrame': 'before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment.', 'description': 'A self-report inventory, the Central Sensitization Inventory (CSI), will be used to assess the overlapping symptom dimensions of Central Sensitivity Syndromes. This measure is intended as a screening instrument to help identify the presence of a Central Sensitivity Syndrome, and to alert clinicians that presenting symptoms may be related to central sensitisation. Part A of the Central Sensitisation Inventory assesses 25 health-related symptoms that are common to Central Sensitivity Syndrome, with total scores ranging from 0-100. Part B (which is not scored) asks if one has previously been diagnosed with one or more specific disorders, including seven separate Central Sensitivity Syndromes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myofascial pain', 'hydrodissection', 'dry needling', 'exercise'], 'conditions': ['Myofascial Pain of Upper Trapezius Muscle']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare interfascial block therapy with commonly used exercise therapy and conventional invasive dry needling therapy, and to evaluate its effectiveness and superiority. Another objective of this study was to evaluate and compare the short-term and long-term effectiveness of interfascial block, dry needling, and exercise therapies on pain, disability, and quality of life in patients with myofascial pain syndrome. In this respect, our study is important in terms of its contribution to the literature.', 'detailedDescription': "The study will include patients who present to the Physical Medicine and Rehabilitation outpatient clinic between July 2025 and May 2026 with clinical symptoms consistent with myofascial pain syndrome in the trapezius muscle. Patients referred to our injection clinic (treatment room) for routine myofascial stretching exercises, dry needling, and interfascial block treatments will be included if they meet the inclusion and exclusion criteria specified below. Demographic data such as age, gender, height, and weight will be recorded. At the initial assessment, patients' VAS (Visual Analog Scale), range of motion in the neck, neck disability scale, pressure pain threshold (PPT) measurements with an algometer, central sensitization scale, and Short Form 12 (SF-12) results will be noted. A total of 78 patients will be included in the study and randomly divided into three groups: Group 1 (Exercise group), Group 2 (Exercise + dry needling group), and Group 3 (Exercise + interfascial block group). Randomization will be done using a sealed envelope method. Group 1 will perform cervical ROM and trapezius facial stretching exercises. Group 2 will perform cervical ROM, trapezius facial stretching exercises, and dry needling of the relevant fascia using Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance. Group 3 will perform cervical ROM and trapezius facial stretching exercises, and interfascial application of a mixture of 1 cc of 2% lidocaine and 4 cc of 0.9% saline under ultrasound guidance. Patients will receive a total of 3 treatment sessions, once a week for 3 weeks. All evaluation parameters will be performed before treatment, 30 minutes after the last session, and 12 weeks after the start of treatment. Within-group and between-group differences will be examined statistically."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myofascial pain in the upper trapezius muscle that has lasted for at least 3 months\n* VAS score of 4 or higher for the current pain\n* Clinically diagnosed with myofascial pain in the trapezius muscle\n* Ages 18 to 55\n* Patients who can follow verbal instructions and have no cognitive deficits\n\nExclusion Criteria:\n\n* Having received interventional injections in the neck and shoulder area within the last 3 months\n* Having received physical therapy within the last 3 months\n* Having received regular nonsteroidal anti-inflammatory and myorelaxant treatment within the last month\n* History of surgery on the affected side (neck or shoulder)\n* Chronic inflammatory disease\n* Acute infection\n* History of malignancy\n* Coagulation disorders\n* Pregnancy\n* Liver and kidney pathologies\n* Drug allergy'}, 'identificationModule': {'nctId': 'NCT07490366', 'briefTitle': 'Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Haydarpasa Numune Training and Research Hospital'}, 'officialTitle': 'Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome', 'orgStudyIdInfo': {'id': '2024KAEK18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise + Dry Needling Group', 'interventionNames': ['Other: Dry Needling + Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise + interfascial block group', 'interventionNames': ['Other: Exercise + interfascial block']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Cervical range of motion and trapezius fascial stretching exercises', 'armGroupLabels': ['Exercise group']}, {'name': 'Dry Needling + Exercise', 'type': 'OTHER', 'description': 'Cervical ROM, fascial stretching exercises for the trapezius muscles, and dry needling of the relevant fascia with Hua Long brand 0.25x25 mm disposable sterile steel acupuncture needles under ultrasound guidance.', 'armGroupLabels': ['Exercise + Dry Needling Group']}, {'name': 'Exercise + interfascial block', 'type': 'OTHER', 'description': 'Cervical range of motion (ROM) and trapezius muscles are treated with fascial stretching exercises and ultrasound-guided interfascial injection of 1 cc of 2% lidocaine + 4 cc of 0.9% saline solution.', 'armGroupLabels': ['Exercise + interfascial block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'state': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Eren Başıbüyük, M.D.', 'role': 'CONTACT', 'email': 'erenbasiboyuk@gmail.com', 'phone': '+905344844832'}], 'facility': 'Haydarpaşa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Eren Başıbüyük, M.D.', 'role': 'CONTACT', 'email': 'erenbasiboyuk@gmail.com', 'phone': '+905344844832'}, {'name': 'Nilgün Mesci, Prof.', 'role': 'CONTACT', 'email': 'nilgunbilgili@yahoo.com', 'phone': '+905336295998'}], 'overallOfficials': [{'name': 'Sibel Süzen Özbayrak', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Haydarpaşa Numune Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Safety concerns'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eren Başıbüyük', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Eren Başıbüyük', 'investigatorAffiliation': 'Haydarpasa Numune Training and Research Hospital'}}}}