Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-20 @ 6:52 PM
Study NCT ID:
NCT06502951
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2024-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}, {'id': 'D014911', 'term': 'Whiplash Injuries'}, {'id': 'D006261', 'term': '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'}, {'id': 'D019838', 'term': 'Neck Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'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': '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': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Headache Intensity (Numeric Pain Rating Scale, 0-10) (Rating Score)', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months', 'description': 'Rating Score on 0-10 scale. Baseline score must exceed 2/10 to be included. Lower scores indicate less pain intensity.\n\nthe study.'}], 'secondaryOutcomes': [{'measure': 'Change in Global Rating of Change Score for Headaches', 'timeFrame': '6 months', 'description': 'Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.'}, {'measure': 'Change in Global Rating of Change Score for Neck Pain', 'timeFrame': '6 months', 'description': 'Rating score for self perceived change with range of -7 to +7. Higher scores indicate greater improvement.'}, {'measure': 'Change in Medication Intake (Frequency of medication intake in last week)', 'timeFrame': 'Baseline, 6 months', 'description': 'Over the counter and prescription medication'}, {'measure': 'Change in Headache Duration (Total hours of headaches in the last week)', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months', 'description': 'Total hours of headaches in the last week'}, {'measure': 'Change in Headache Frequency (Number of headaches in the last week)', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months', 'description': 'Number of headaches in the last week'}, {'measure': 'Change in Disability (Neck Disability Index, 0-50 points)', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months', 'description': '10 Questions each worth 0-5 points with maximum score of 50 points possible. Lower scores indicate lower disability levels. Baseline score must exceed 10/50 to be included in study.'}, {'measure': 'Change in Neck Pain Intensity (Numeric Pain Rating Scale, 0-10 points)', 'timeFrame': 'Baseline, 4 weeks, 3 months, 6 months', 'description': 'Rating score 0-10 points. Lower scores indicate lower pain intensity. Baseline score must exceed 2/10 to be included'}, {'measure': 'Change in Pain Catastrophizing Scale (0-52 points)', 'timeFrame': 'Baseline, 6 months', 'description': '13 questions each worth 0-4 points with maximum score of 52 points. Lower scores indicate less pain catastrophizing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Headache', 'Whiplash'], 'conditions': ['Cervicogenic Headache', 'Whiplash Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches associated with type II whiplash associated disorder: 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 and type II whiplash associated disorder 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 upper cervical high-velocity low-amplitude thrust manipulation, or (2) exercise and non-thrust mobilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subacute (\\> 4 weeks) or chronic type II whiplash associated disorder. Neck pain and headache following motor vehicle accident with reduced range of motion \\& point tenderness.\n2. Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria.\n3. Headache frequency of at least one per week since the whiplash injury.\n4. Headache intensity of greater than 2/10 on the NPRS.\n5. Neck pain intensity of greater than 2/10 on the NPRS.\n6. Neck Disability Index score of greater than 10/50 on the NDI.\n\nExclusion Criteria:\n\n1. WAD I (neck pain, but no physical signs), WAD III (neck pain and neurological signs), WAD IV (neck pain + fracture/dislocation).\n2. Positive screen for cervical radiography (Canadian C-Spine Rules).\n3. Bilateral headaches (typical of tension type headaches).\n4. Diagnosis / signs \\& symptoms of concussion (confusion, disorientation, or impaired consciousness; loss of memory for events immediately before or after the MVA; and one or more of the following: nausea, vomiting, visual disturbances, vertigo, gait and/or postural imbalance, and impaired memory and/or concentration).\n5. Diagnosis of fibromyalgia.\n6. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia, or hyperlipidemia.\n7. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e., tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.).\n8. Diagnosis of cervical spinal stenosis.\n9. Bilateral upper extremity symptoms.\n10. Evidence of central nervous system 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, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).\n11. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:\n\n 1. Muscle weakness involving a major muscle group of the upper extremity.\n 2. Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors\n 3. Diminished or absent sensation to pinprick in any UE dermatome.\n12. Prior surgery to the head, neck, or thoracic spine.\n13. Physical therapy or chiropractic treatment for neck pain and/or headache in the past 3 months.\n14. Any condition that might contraindicate spinal manipulative therapy or dry needling."}, 'identificationModule': {'nctId': 'NCT06502951', 'briefTitle': 'Manipulation and Dry Needling in Patients With Cervicogenic Headache and WAD II', 'organization': {'class': 'OTHER', 'fullName': 'Alabama Physical Therapy & Acupuncture'}, 'officialTitle': 'Upper Cervical Spine Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache and Type II Whiplash Associated Disorder: a Multi-center Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AAMT0018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry Needling,Thrust Manipulation', 'description': 'Dry needling to the craniofacial, upper cervical, and cervicothoracic regions. High-velocity thrust manipulation to the upper cervical spine, mid/lower cervical spine, and cervicothoracic spinal regions.', 'interventionNames': ['Other: Dry Needling,Thrust Manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise,Non-thrust Mobilization', 'description': 'Nonthrust joint mobilization to the upper cervical spine, mid/lower cervical spine, and cervicothoracic spinal regions. Cranio-cervical flexion exercises, peri-scapular progressive resistance exercises, and electrothermal modalities', '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', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Dunning, PhD, DPT', 'role': 'CONTACT', 'email': 'jamesdunning@hotmail.com', 'phone': '801-707-9056'}, {'name': 'Ian Young, DSc PT', 'role': 'CONTACT', 'email': 'tybeewellness@gmail.com', 'phone': '912-433-3531'}], 'facility': 'Alabama Physical Therapy & Acupuncture', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}], 'centralContacts': [{'name': 'James Dunning, PhD, DPT', 'role': 'CONTACT', 'email': 'drjamesdunning@gmail.com', 'phone': '801-707-9056'}, {'name': 'Ian Young, DSc, PT', 'role': 'CONTACT', 'email': 'tybeewellness@gmail.com', 'phone': '912-433-3531'}], 'overallOfficials': [{'name': 'James Dunning, PhD, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Academy of Manipulative Therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alabama Physical Therapy & Acupuncture', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, DPT, FAAOMPT', 'investigatorFullName': 'James Dunning, DPT, MSc, FAAOMPT', 'investigatorAffiliation': 'Alabama Physical Therapy & Acupuncture'}}}}