Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine
2 other identifiers
interventional
104
1 country
1
Brief Summary
This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for migraine. If the method proves to be effective, it will provide a new non-pharmacological treatment option for migraine. This is especially important since some migraineurs do not tolerate acute and/or prophylactic medicine, due to side effects or contraindications due to comorbidity of other diseases while others do not have effect. Thus, alternative treatment options are warranted. The applied methodology of the study will aim towards the highest possible research standards. This international study is a collaboration between Akershus University Hospital, University of Oslo (UiO), Norway and Macquarie University, Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and medicine. By increasing the methodological quality of the investigators research to a very high level, the investigators see the method to work as a guide to increase the quality of chiropractic research in the future, as previous randomized clinical trials (RCTs) of migraine used methodology showing room for improvement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJanuary 10, 2019
January 1, 2019
2.1 years
December 2, 2012
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number og headache days
1. 25% reduction in number of headache days between active treatment and sham. 2. 25% reduction in number of headache days between active treatment and control group.
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Secondary Outcomes (4)
Headache duration
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Self reported VAS
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Headache index
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Headache medication
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Other Outcomes (1)
Sub analysis on x-ray findings
Pre-treatment
Study Arms (3)
Chiropractic Spinal Manipulative Therapy
ACTIVE COMPARATORActive chiropractic spinal manipulative treatment
Sham manipulation
SHAM COMPARATORSham chiropractic manipulative therapy
Control group
NO INTERVENTIONNo intervention, follow headache diary
Interventions
Chiropractic spinal manipulative therapy
Eligibility Criteria
You may qualify if:
- Migraine according to the diagnostic criteria of the ICHD-II (8)
- At least one migraine attack per month
- Age 18-70 years
You may not qualify if:
- Contraindication to spinal manipulation
- Chiropractic treatment within the last 12 months
- Radiculopathy
- Depression
- Pregnancy
- Participants whom become pregnant during the migraine trial will also be excluded from analysis from the time of pregnancy
- Participants who change their prophylactic medical regime for headaches will be excluded in the analysis from the time of change
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Centre, Akershus University Hospital
Lørenskog, 1478, Norway
Related Publications (5)
Chaibi A, Tuchin PJ, Russell MB. Manual therapies for migraine: a systematic review. J Headache Pain. 2011 Apr;12(2):127-33. doi: 10.1007/s10194-011-0296-6. Epub 2011 Feb 5.
PMID: 21298314BACKGROUNDChaibi A, Saltyte Benth J, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for migraine: a study protocol of a single-blinded placebo-controlled randomised clinical trial. BMJ Open. 2015 Nov 19;5(11):e008095. doi: 10.1136/bmjopen-2015-008095.
PMID: 26586317BACKGROUNDChaibi A, Benth JS, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial. Eur J Neurol. 2017 Jan;24(1):143-153. doi: 10.1111/ene.13166. Epub 2016 Oct 2.
PMID: 27696633RESULTChaibi A, Saltyte Benth J, Bjorn Russell M. Validation of Placebo in a Manual Therapy Randomized Controlled Trial. Sci Rep. 2015 Jul 6;5:11774. doi: 10.1038/srep11774.
PMID: 26145718RESULTChaibi A, Benth JS, Tuchin PJ, Russell MB. Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs. Musculoskelet Sci Pract. 2017 Jun;29:66-71. doi: 10.1016/j.msksp.2017.03.003. Epub 2017 Mar 14.
PMID: 28324697RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael B Russell, Professor
Head and Neck Research Group, Research Centre, Akershus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
December 2, 2012
First Posted
December 5, 2012
Study Start
February 1, 2013
Primary Completion
March 1, 2015
Study Completion
September 1, 2015
Last Updated
January 10, 2019
Record last verified: 2019-01