Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02373605
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D020393', 'term': 'Manipulation, Spinal'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-02-23', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Headache Intensity (NPRS) (Rating Score)', 'timeFrame': 'Baseline, 1 week, 4 weeks, 3 months', 'description': 'Rating Score. Baseline score must exceed 2/10 to be included in the study.'}, {'measure': 'Change in Headache Frequency (Number of headaches in the last week)', 'timeFrame': 'Baseline, 1 week, 4 weeks, 3 months', 'description': 'Number of headaches in the last week'}, {'measure': 'Change in Disability (NDI 0-50 points)', 'timeFrame': 'Baseline, 1 week, 4 weeks, 3 months', 'description': '10 Questions each worth 0-5 points with maximum score of 50 points possible. Baseline score must exceed 10/50 to be included in study.'}], 'secondaryOutcomes': [{'measure': 'Change in Global Rating of Change Score', 'timeFrame': '1 week, 4 weeks, 3 months'}, {'measure': 'Change in Medication Intake (Frequency of medication intake in last week)', 'timeFrame': 'Baseline, 3 months'}, {'measure': 'Change in Headache Duration (Total hours of headaches in the last week)', 'timeFrame': 'Baseline, 1 week, 4 weeks, 3 months', 'description': 'Total hours of headaches in the last week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervicogenic Headaches']}, 'referencesModule': {'references': [{'pmid': '33065273', 'type': 'DERIVED', 'citation': 'Dunning J, Butts R, Zacharko N, Fandry K, Young I, Wheeler K, Day J, Fernandez-de-Las-Penas C. Spinal manipulation and perineural electrical dry needling in patients with cervicogenic headache: a multicenter randomized clinical trial. Spine J. 2021 Feb;21(2):284-295. doi: 10.1016/j.spinee.2020.10.008. Epub 2020 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.', 'detailedDescription': 'Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria\n2. Headache frequency of at least one per week for a minimum of 3 months\n3. Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50\n\nExclusion Criteria:\n\n1. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia\n2. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.\n3. History of whiplash injury within the last 6 weeks\n4. Diagnosis of cervical stenosis\n5. Bilateral upper extremity symptoms\n6. Evidence of CNS involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).\n7. Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:\n\n 1. Muscle weakness involving a major muscle group of the upper extremity.\n 2. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors\n 3. Diminished or absent sensation to pinprick in any UE dermatome.\n8. Prior surgery to neck of thoracic spine\n9. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches\n10. PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.\n11. Any condition that might contraindicate spinal manipulative therapy."}, 'identificationModule': {'nctId': 'NCT02373605', 'briefTitle': 'Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Alabama Physical Therapy & Acupuncture'}, 'officialTitle': 'Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache: a Multi-center Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AAMT0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry Needling,Thrust Manipulation', 'interventionNames': ['Other: Dry Needling,Thrust Manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise,Non-thrust Mobilization', 'interventionNames': ['Other: Exercise,Non-thrust Mobilization']}], 'interventions': [{'name': 'Dry Needling,Thrust Manipulation', 'type': 'OTHER', 'otherNames': ['Spinal Manipulation', 'Dry Needling'], 'description': 'HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.', 'armGroupLabels': ['Dry Needling,Thrust Manipulation']}, {'name': 'Exercise,Non-thrust Mobilization', 'type': 'OTHER', 'otherNames': ['Exercise', 'Non-thrust Mobilization'], 'description': 'Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.', 'armGroupLabels': ['Exercise,Non-thrust Mobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Physical Therapy & Acupuncture', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}], 'overallOfficials': [{'name': 'James Dunning, DPT PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Academy of Manipulative Therapy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alabama Physical Therapy & Acupuncture', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DPT MSc FAAOMPT', 'investigatorFullName': 'James Dunning, DPT, MSc, FAAOMPT', 'investigatorAffiliation': 'Alabama Physical Therapy & Acupuncture'}}}}