Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-04 @ 2:14 PM
Study NCT ID:
NCT00246350
Status:
COMPLETED
Last Update Posted:
2010-11-22
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Manipulation for Treatment of Chronic Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D008405', 'term': 'Massage'}, {'id': 'D020393', 'term': 'Manipulation, Spinal'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-19', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-10-27', 'lastUpdatePostDateStruct': {'date': '2010-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Von Korff pain scale for headaches'}], 'secondaryOutcomes': [{'measure': 'Modified Von Korff disability scale for headaches'}, {'measure': 'Number of cervicogenic headaches'}, {'measure': 'general physical and mental health status'}, {'measure': 'patient satisfaction'}, {'measure': 'neck pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Headaches', 'Spinal manipulation', 'Massage', 'chiropractic'], 'conditions': ['Headache Disorders']}, 'referencesModule': {'references': [{'pmid': '15614241', 'type': 'BACKGROUND', 'citation': 'Haas M, Groupp E, Aickin M, Fairweather A, Ganger B, Attwood M, Cummins C, Baffes L. Dose response for chiropractic care of chronic cervicogenic headache and associated neck pain: a randomized pilot study. J Manipulative Physiol Ther. 2004 Nov-Dec;27(9):547-53. doi: 10.1016/j.jmpt.2004.10.007.'}, {'pmid': '19837005', 'type': 'RESULT', 'citation': 'Haas M, Spegman A, Peterson D, Aickin M, Vavrek D. Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Spine J. 2010 Feb;10(2):117-28. doi: 10.1016/j.spinee.2009.09.002.'}, {'pmid': '20114095', 'type': 'RESULT', 'citation': 'Haas M, Aickin M, Vavrek D. A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache. J Manipulative Physiol Ther. 2010 Jan;33(1):5-13. doi: 10.1016/j.jmpt.2009.11.007.'}, {'pmid': '20497573', 'type': 'RESULT', 'citation': 'Haas M, Schneider M, Vavrek D. Illustrating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache. Chiropr Osteopat. 2010 May 24;18:9. doi: 10.1186/1746-1340-18-9.'}, {'pmid': '20605552', 'type': 'RESULT', 'citation': 'Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther. 2010 Jun;33(5):338-48. doi: 10.1016/j.jmpt.2010.05.004.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.', 'detailedDescription': "Spinal manipulation is the signature therapy of chiropractic care involving manual adjustment of joints in the neck and back. Data indicate that spinal manipulation is an effective treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are caused by problems in the cervical spine. However, studies that have determined the optimal frequency and duration of spinal manipulation treatment are limited. This study will determine the feasibility of conducting a large spinal manipulation clinical trial. This study will also determine the effectiveness of spinal manipulation in treating cervicogenic headaches and neck pain and the optimal number of treatments necessary to sustain spinal manipulation benefits.\n\nParticipants will be randomly assigned to receive weekly sessions of either spinal manipulation or light massage treatments for 8 to 16 weeks. Self-report scales will be used to assess participants' headache frequency, pain, satisfaction with treatment, and overall physical and mental health. Assessments will occur at study entry, at the end of each week, and at the end of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of cervicogenic headaches\n\nExclusion Criteria:\n\n* Contraindications to spinal manipulation or massage\n* Use of chiropractic or therapeutic massage care prior to study entry\n* Use of any prophylactic prescription medication\n* Involved in any type of lawsuit prior to study entry\n* Headaches with several different causes'}, 'identificationModule': {'nctId': 'NCT00246350', 'briefTitle': 'Spinal Manipulation for Treatment of Chronic Headaches', 'organization': {'class': 'OTHER', 'fullName': 'University of Western States'}, 'officialTitle': 'Dose-Response of Manipulation for Chronic Headache', 'orgStudyIdInfo': {'id': 'R21AT002324', 'link': 'https://reporter.nih.gov/quickSearch/R21AT002324', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21AT002324', 'link': 'https://reporter.nih.gov/quickSearch/R21AT002324', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '8 light massage treatments', 'interventionNames': ['Procedure: massage']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '16 light massage treatments', 'interventionNames': ['Procedure: massage']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '8 spinal manipulation treatments', 'interventionNames': ['Procedure: spinal manipulation']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '16 spinal manipulation treatments', 'interventionNames': ['Procedure: Spinal manipulation']}], 'interventions': [{'name': 'massage', 'type': 'PROCEDURE', 'description': '8 light massage treatments and hot pack', 'armGroupLabels': ['1']}, {'name': 'massage', 'type': 'PROCEDURE', 'description': '16 light massage treatments and hot packs', 'armGroupLabels': ['2']}, {'name': 'spinal manipulation', 'type': 'PROCEDURE', 'description': '8 high velocity, low amplitude spinal manipulation treatments and hot pack', 'armGroupLabels': ['3']}, {'name': 'Spinal manipulation', 'type': 'PROCEDURE', 'description': '16 high velocity, low amplitude spinal manipulation treatments and hot pack', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97230', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Western States Chiropractic College', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Mitchell Haas, DC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western States'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Western States', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}]}}}