Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option for Migraine

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Akershus
Sponsor:
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
  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 ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014