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Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01741714
First Posted: December 5, 2012
Last Update Posted: December 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Norwegian Chiropractic Association
Information provided by (Responsible Party):
Aleksander Chaibi, University Hospital, Akershus
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Aleksander Chaibi, University Hospital, Akershus:

Primary Outcome Measures:
  • Number og headache days [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
    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.


Secondary Outcome Measures:
  • Headache duration [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
    1. 25% reduction in headache duration in hours between active treatment and sham.
    2. 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 ]
    1. 25% self-reported improvement on VAS between active treatment and sham.
    2. 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 ]
    1. 25% reduction in headache index (frequency x duration x intensity) between active treatment and sham.
    2. 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 ]
    1. 50% reduction in headache medication between active treatment and sham.
    2. 50% reduction in headache medication between active treatment and control group.


Other Outcome Measures:
  • Sub analysis on x-ray findings [ Time Frame: Pre-treatment ]
    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.


Enrollment: 104
Study Start Date: February 2013
Study Completion Date: September 2015
Primary Completion Date: March 2015 (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
Chiropractic spinal manipulative therapy
Sham Comparator: Sham manipulation
Sham chiropractic manipulative therapy
Other: Sham chiropractic manipulative therapy
Sham manipulation
No Intervention: Control group
No intervention, follow headache diary

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741714


Locations
Norway
Research Centre, Akershus University Hospital
Lørenskog, Norway, 1478
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aleksander Chaibi, PhD student, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01741714     History of Changes
Other Study ID Numbers: Migraine-K34KSF-AHUS
2829002 ( Other Grant/Funding Number: 2829002 )
First Submitted: December 2, 2012
First Posted: December 5, 2012
Last Update Posted: December 31, 2015
Last Verified: December 2015

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