Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 2:27 AM
Study NCT ID:
NCT06257992
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Dry Needling of Active Trigger Points in Neck Muscles in Patients With Chronic Cervical 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'}], '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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cervical Pain Intensity', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months', 'description': 'For the Assesment of cervical pain intensity the Numeric Pain Rating Scale (NPRS) was used.'}, {'measure': 'Neck Disability Index', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months', 'description': 'For the assesment of perceived neck disability the neck disability index was used.'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months', 'description': 'For the assesment of pressure pain threshold of active trigger points a digital algometer was used'}], 'secondaryOutcomes': [{'measure': 'Cervical range of movement', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months', 'description': 'For the assesment of cervical range of movement the universal goniometer was used'}, {'measure': 'Cervical muscles Electromyography', 'timeFrame': 'Change between baseline (immediately before intervention) and post intervention (immediately after intervention), after 1month and 3 months', 'description': 'For the assesment of cervical muscles electromyographic activity Trigno Avanti sensor was used.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Pain']}, 'referencesModule': {'references': [{'pmid': '27537209', 'type': 'BACKGROUND', 'citation': 'Cerezo-Tellez E, Torres-Lacomba M, Fuentes-Gallardo I, Perez-Munoz M, Mayoral-Del-Moral O, Lluch-Girbes E, Prieto-Valiente L, Falla D. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial. Pain. 2016 Sep;157(9):1905-1917. doi: 10.1097/j.pain.0000000000000591.'}, {'pmid': '21882489', 'type': 'BACKGROUND', 'citation': 'Fernandez-de-las-Penas C, Alonso-Blanco C, Miangolarra JC. Myofascial trigger points in subjects presenting with mechanical neck pain: a blinded, controlled study. Man Ther. 2007 Feb;12(1):29-33. doi: 10.1016/j.math.2006.02.002.'}, {'pmid': '34114639', 'type': 'BACKGROUND', 'citation': 'Navarro-Santana MJ, Sanchez-Infante J, Gomez-Chiguano GF, Cleland JA, Fernandez-de-Las-Penas C, Martin-Casas P, Plaza-Manzano G. Dry Needling Versus Trigger Point Injection for Neck Pain Symptoms Associated with Myofascial Trigger Points: A Systematic Review and Meta-Analysis. Pain Med. 2022 Mar 2;23(3):515-525. doi: 10.1093/pm/pnab188.'}, {'pmid': '30935326', 'type': 'BACKGROUND', 'citation': 'Ball AM, Finnegan M, Koppenhaver S, Freres W, Dommerholt J, Mayoral Del Moral O, Bron C, Moore R, Ball EE, Gaffney EE. The relative risk to the femoral nerve as a function of patient positioning: potential implications for trigger point dry needling of the iliacus muscle. J Man Manip Ther. 2019 Jul;27(3):162-171. doi: 10.1080/10669817.2019.1568699. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': "Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be older than 18 years old\n* Sign informed consent form prior to participating in this study\n* Have chronic cervical pain diagnosis of their primary care doctor.\n* Have one or more active myofascial trigger point in the cervical muscles according to the criteria established by Simons et al.\n\nExclusion Criteria:\n\n* Major trauma on cervical spine stated from the medical history\n* Inflammatory, hormonal or neurological disorders\n* Have contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, wound in the puncture area, metal allergies, cancer or systemic diseases, or belonephobia)\n* Having received physiotherapy treatment for the condition in the past month'}, 'identificationModule': {'nctId': 'NCT06257992', 'briefTitle': 'Effectiveness of Dry Needling of Active Trigger Points in Neck Muscles in Patients With Chronic Cervical Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Zaragoza'}, 'officialTitle': 'Effectiveness of Dry Needling of Active Trigger Points in Neck Muscles in Patients With Chronic Cervical Pain', 'orgStudyIdInfo': {'id': 'RAT 2022-53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry Needling Group', 'interventionNames': ['Other: Dry Needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretch Group', 'interventionNames': ['Other: Stretch']}], 'interventions': [{'name': 'Dry Needling', 'type': 'OTHER', 'description': "3 treatments of dry needling to inactivate all active trigger points found in patient's cervical muscles.", 'armGroupLabels': ['Dry Needling Group']}, {'name': 'Stretch', 'type': 'OTHER', 'description': "3 treatments of stretch applied to all cervical muscles that present active trigger points in patient's cervical muscles.", 'armGroupLabels': ['Stretch Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'contacts': [{'name': 'Jesús Marcen', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'info@centroclinicoomt.es', 'phone': '+34644161870'}], 'facility': 'Centro Clínico de Fisioterapia OMT-E', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'centralContacts': [{'name': 'Julian Müller-Thyssen Uriarte', 'role': 'CONTACT', 'email': 'julianmuller.jmt@gmail.com', 'phone': '+34 0633673021'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Julian Müller-Thyssen Uriarte', 'investigatorAffiliation': 'Universidad de Zaragoza'}}}}