Spinal Manipulation for Treatment of Chronic Headaches
Primary Purpose
Headache Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
massage
massage
spinal manipulation
Spinal manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Headache Disorders focused on measuring Headaches, Spinal manipulation, Massage, chiropractic
Eligibility Criteria
Inclusion Criteria: History of cervicogenic headaches Exclusion Criteria: Contraindications to spinal manipulation or massage Use of chiropractic or therapeutic massage care prior to study entry Use of any prophylactic prescription medication Involved in any type of lawsuit prior to study entry Headaches with several different causes
Sites / Locations
- Western States Chiropractic College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
8 light massage treatments
16 light massage treatments
8 spinal manipulation treatments
16 spinal manipulation treatments
Outcomes
Primary Outcome Measures
Modified Von Korff pain scale for headaches
Secondary Outcome Measures
Modified Von Korff disability scale for headaches
Number of cervicogenic headaches
general physical and mental health status
patient satisfaction
neck pain
Full Information
NCT ID
NCT00246350
First Posted
September 13, 2005
Last Updated
November 19, 2010
Sponsor
University of Western States
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00246350
Brief Title
Spinal Manipulation for Treatment of Chronic Headaches
Official Title
Dose-Response of Manipulation for Chronic Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Western States
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
Participants 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders
Keywords
Headaches, Spinal manipulation, Massage, chiropractic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
8 light massage treatments
Arm Title
2
Arm Type
Active Comparator
Arm Description
16 light massage treatments
Arm Title
3
Arm Type
Experimental
Arm Description
8 spinal manipulation treatments
Arm Title
4
Arm Type
Experimental
Arm Description
16 spinal manipulation treatments
Intervention Type
Procedure
Intervention Name(s)
massage
Intervention Description
8 light massage treatments and hot pack
Intervention Type
Procedure
Intervention Name(s)
massage
Intervention Description
16 light massage treatments and hot packs
Intervention Type
Procedure
Intervention Name(s)
spinal manipulation
Intervention Description
8 high velocity, low amplitude spinal manipulation treatments and hot pack
Intervention Type
Procedure
Intervention Name(s)
Spinal manipulation
Intervention Description
16 high velocity, low amplitude spinal manipulation treatments and hot pack
Primary Outcome Measure Information:
Title
Modified Von Korff pain scale for headaches
Secondary Outcome Measure Information:
Title
Modified Von Korff disability scale for headaches
Title
Number of cervicogenic headaches
Title
general physical and mental health status
Title
patient satisfaction
Title
neck pain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of cervicogenic headaches
Exclusion Criteria:
Contraindications to spinal manipulation or massage
Use of chiropractic or therapeutic massage care prior to study entry
Use of any prophylactic prescription medication
Involved in any type of lawsuit prior to study entry
Headaches with several different causes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Haas, DC
Organizational Affiliation
University of Western States
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western States Chiropractic College
City
Portland
State/Province
Oregon
ZIP/Postal Code
97230
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15614241
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.
Results Reference
background
PubMed Identifier
19837005
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.
Results Reference
result
PubMed Identifier
20114095
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.
Results Reference
result
PubMed Identifier
20497573
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.
Results Reference
result
PubMed Identifier
20605552
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.
Results Reference
result
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Spinal Manipulation for Treatment of Chronic Headaches
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