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Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache

This study has been completed.
Sponsor:
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Norwegian Chiropractic Association
Information provided by (Responsible Party):
Aleksander Chaibi, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01687881
First received: September 11, 2012
Last updated: December 30, 2015
Last verified: December 2015
History of Changes
  Purpose

This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for cervicogenic headache (CEH). If the method proves to be effective, it will provide a new non-pharmacological treatment option for CEH. This is especially important since pharmacological management has minor effect in CEH, and 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, Innlandet Hospital and 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 CEH used methodology showing room for improvement.

Study hypothesis:

CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low amplitude) and no intervention (control group).


Condition Intervention Phase
Cervicogenic Headache
 Other: Chiropractic
Other: Sham Chiropractic
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache? A Randomized Controlled Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Number of 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: Change formbaseline to post-treatment, 3, 6, 12 months follow-up ] [ Designated as safety issue: No ]
    Sub-analysis will be done on participants with structural deformities vs. normal x-ray findings.
Enrollment: 19
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham Chiropractic
Sham Chiropractic manipulative therapy.
 Other: Sham Chiropractic
Sham manipulation
No Intervention: Control group
No intervention: Control group.
Active Comparator: Chiropractic Spinal Manipulative Therapy
Active intervention: Chiropractic Spinal Manipulative Therapy
 Other: Chiropractic
Chiropractic Spinal Manipulative Therapy

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CEH according to at least three major criteria of the CHISG not including occipital nerve blockage
  • 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: NCT01687881

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:

Responsible Party: Aleksander Chaibi, PhD student, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01687881     History of Changes
Other Study ID Numbers: CEH-K34KSF-AHUS  2829002 
Study First Received: September 11, 2012
Last Updated: December 30, 2015
Health Authority: Norway: Ethics Committee
Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital, Akershus:
Chiropractic
Manipulative therapy
Cervicogenic headache

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 28, 2016