Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 11:01 AM
Study NCT ID:
NCT03787706
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2018-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dry Needling and Electromyographic Changes in Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'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': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2018-12-22', 'studyFirstSubmitQcDate': '2018-12-22', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in electromyographic activity of the neck superficial flexor muscles before and after the intervention', 'timeFrame': 'Baseline and 5 minutes after treatment', 'description': 'Bipolar surface EMG will be recorded with pairs of electrodes positioned 20mm apart and fixed firmly with an adhesive tape bilaterally over the sternocleidomastoid, the anterior scalene, the upper trapezius and the splenius capitis muscles.'}], 'secondaryOutcomes': [{'measure': 'Changes in neck pain intensity with a numerical pain rate scale before and after the intervention', 'timeFrame': 'Baseline and 5 minutes after treatment', 'description': 'A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous neck pain intensity'}, {'measure': 'Changes in widespread pressure pain sensitivity before and after the intervention', 'timeFrame': 'Baseline and 5 minutes after treatment', 'description': 'Pressure pain thresholds will be assessed over C5/C6 zygapophyseal joints, second metacarpal, and tibialis anterior muscle'}, {'measure': 'Changes in cervical range of motion before and after the intervention', 'timeFrame': 'Baseline and 5 minutes after treatment', 'description': 'Active cervical range of motion will be assessed with a Cervical Range of Motion (CROM) device in all cervical motions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neck Pain', 'Trigger points', 'Dry needling', 'Cranio-cervical flexion test'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '35179608', 'type': 'DERIVED', 'citation': 'Rodriguez-Jimenez J, Ortega-Santiago R, Bonilla-Barba L, Falla D, Fernandez-de-Las-Penas C, Florencio LL. Immediate Effects of Dry Needing or Manual Pressure Release of Upper Trapezius Trigger Points on Muscle Activity During the Craniocervical Flexion Test in People with Chronic Neck Pain: A Randomized Clinical Trial. Pain Med. 2022 Sep 30;23(10):1717-1725. doi: 10.1093/pm/pnac034.'}]}, 'descriptionModule': {'briefSummary': 'There is evidence suggesting that patients with mechanical neck pain exhibit higher activity of the superficial neck flexor muscles during the execution of the cranio-cervical flexion test. In addition, some studies have reported the presence of active trigger points in the neck flexor and extensor muscles. Since preliminary evidence suggests that trigger points can affect motor control behaviour, it is possible that management of these trigger points with dry needling could be effective for improving muscle activity during low-load activities, such as the cranio-cervical flexion test. Therefore, the aim of this study will be to investigate the effects on electromyographical activity, pressure pain thresholds and cervical range of motion after the application of dry needling over active TrPs in the upper trapezius muscle in patients with mechanical neck pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneralized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature.\n\nExclusion Criteria:\n\n* whiplash injury;\n* previous cervical or thoracic surgery;\n* cervical radiculopathy or myelopathy;\n* diagnosis of fibromyalgia syndrome;\n* having undergone physical therapy in the previous 6 months;\n* less than 18 or greater than 55 years of age\n* fear to needles'}, 'identificationModule': {'nctId': 'NCT03787706', 'briefTitle': 'Dry Needling and Electromyographic Changes in Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Electromyographic Changes in the Cranio-Cervical Flexion Test After Dry Needling of the Upper Trapezius Muscle in Patients With Mechanical Neck Pain', 'orgStudyIdInfo': {'id': 'URJC3010201812618'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry needling', 'description': 'Patients will receive dry needling over active trigger points in the upper trapezius muscle', 'interventionNames': ['Other: Dry Needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Therapy', 'description': 'Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle', 'interventionNames': ['Other: Manual Therapy']}], 'interventions': [{'name': 'Dry Needling', 'type': 'OTHER', 'description': 'Patients will receive dry needling over active trigger points in the upper trapezius muscle', 'armGroupLabels': ['Dry needling']}, {'name': 'Manual Therapy', 'type': 'OTHER', 'description': 'Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle', 'armGroupLabels': ['Manual Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28921', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Cesar Fernandez-de-Las-Peñas', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department', 'investigatorFullName': 'César Fernández-de-las-Peñas', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}