Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine
This study is currently recruiting participants.
Verified December 2012 by University Hospital, Akershus
Sponsor:
University Hospital, Akershus
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Norwegian Chiropractic Association
Information provided by (Responsible Party):
Aleksander Chaibi, Akershus University College
ClinicalTrials.gov Identifier:
NCT01741714
First received: December 2, 2012
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine With Aura Migraine Without Aura |
Other: Sham chiropractic manipulative therapy Other: Chiropractic spinal manipulative therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine? A Randomized Controlled Clinical Trial |
Resource links provided by NLM:
Further study details as provided by University Hospital, Akershus:
Primary Outcome Measures:
- Number og headache days [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ] [ Designated as safety issue: No ]
- 25% reduction in number of headache days between active treatment and sham.
- 25% reduction in number of headache days between active treatment and control group.
Secondary Outcome Measures:
- Headache duration [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ] [ Designated as safety issue: No ]
- 25% reduction in headache duration in hours between active treatment and sham.
- 25% reduction in headache duration in hours between active treatment and control group.
- Self reported VAS [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ] [ Designated as safety issue: No ]
- 25% self-reported improvement on VAS between active treatment and sham.
- 25% self-reported improvement on VAS between active treatment and control group.
- Headache index [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ] [ Designated as safety issue: No ]
- 25% reduction in headache index (frequency x duration x intensity) between active treatment and sham.
- 25% reduction in headache index between active treatment and control group.
- Headache medication [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ] [ Designated as safety issue: No ]
- 50% reduction in headache medication between active treatment and sham.
- 50% reduction in headache medication between active treatment and control group.
Other Outcome Measures:
- Sub analysis on x-ray findings [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]As there are no validated x-ray assessment forms a descriptive sub-analysis will be done on participants with structural deformities vs. normal x-ray findings. Structural deformities include postural assessment, joint and disc integrity, vertebral misalignments and ruling out pathology prior to CSMT.
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Chiropractic Spinal Manipulative Therapy
Active chiropractic spinal manipulative treatment
|
Other: Chiropractic spinal manipulative therapy |
|
Sham Comparator: Sham manipulation
Sham chiropractic manipulative therapy
|
Other: Sham chiropractic manipulative therapy |
|
No Intervention: Control group
No intervention, follow headache diary
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Migraine according to the diagnostic criteria of the ICHD-II (8)
- At least one migraine attack per month
- Age 18-70 years
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741714
Locations
| Norway | |
| Research Centre, Akershus University Hospital | Recruiting |
| Lørenskog, Norway, 1478 | |
| Contact: Michael B Russell, Professor + 47 67 96 83 81 m.b.russell@medisin.uio.no | |
| Contact: Karin A Vassbakk, dep. manager +47 480 92 669 Karin.Anne.Vassbakk@ahus.no | |
| Principal Investigator: Aleksander Chaibi, PhD student | |
Sponsors and Collaborators
University Hospital, Akershus
Norwegian Foundation for Health and Rehabilitation
Norwegian Chiropractic Association
Investigators
| Study Director: | Michael B Russell, Professor | Head and Neck Research Group, Research Centre, Akershus University Hospital |
More Information
Publications:
| Responsible Party: | Aleksander Chaibi, PhD student, Akershus University College |
| ClinicalTrials.gov Identifier: | NCT01741714 History of Changes |
| Other Study ID Numbers: | Migraine-K34KSF-AHUS, 2829002 |
| Study First Received: | December 2, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Norway: Regional Ethics Commitee Norway: Norwegian Social Science Data Service |
Additional relevant MeSH terms:
|
Migraine Disorders Migraine with Aura Migraine without Aura Headache Disorders, Primary |
Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013