Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache
Condition: Cervicogenic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      Cervicogenic headache (CEH) is a symptomatic headache characterized by chronic unilateral
      headache and symptoms and signs of neck involvement. CEH is often worsened by neck movement,
      sustained awkward head position, external pressure over the upper cervical or occipital
      region on the symptomatic side. Abolition of the headache following diagnostic anesthetic
      blocks of cervical structures or local factors in neck give evidence that the pain is
      attributed to a neck disorder or lesion. The prevalence of CEH is 0.2% in the general
      population of Akershus County, i.e. 9,000 Norwegians have CEH. However, the prevalence varies
      between 0.4-4.1% in studies applying less rigorous diagnostic criteria. The efficacy of
      pharmacological management in CEH is poor. Patients suffering from CEH are commonly treated
      with CSMT, but the methodology has one or more shortcomings in all studies. In addition, the
      RCTs mostly included participant with infrequent CEH and did not follow the recommended
      clinical guidelines by the International Headache Society (IHS) of intervention of at least
      three months. An analysis of the literature as well as a recent pilot study suggests that
      CSMT has an effect on headache intensity and duration, and medication intake. However, a
      randomized controlled clinical trial with high methodological quality on CEH still remains to
      be conducted.

      The RCT is single blinded, placebo-controlled trial of CSMT using the Gonstead method vs.
      sham manipulation and control group. If the treatment shows to be effective, the participants
      whom receive sham manipulation or control will be offered true intervention after the
      follow-up period and free of charge. This study will follow the recommendations set by the
      clinical trial guidelines from the IHS, while the methodological quality control will in
      general follow previous suggested criteria and the CONSORT statements.

      Patients will be recruited through Akershus University Hospital and Innlandet Hospital,
      Norway as well as through media advertising in Akershus and Oslo County. The diagnose is set
      by a chiropractor and a neurologist with experience in headache.

      The clinical trials consist of three stages: Run-in, intervention (treatment) and follow-up.

      One month of base line data collection where participants will fill-in a diagnostic headache
      diary. Baseline demographics and clinical characteristics will be presented in tables with
      mean and standard deviation (SD) for each group.

      The participants will be randomized by drawing prepared sealed lots. Each lot includes three
      different interventions, i.e active treatment, sham manipulation and control group. The first
      three participants will draw from the same lot until all three interventions are used. The
      next lot with three interventions is then followed by the next three participants.

      The RCTs will be conducted by an experienced chiropractor. Active treatment consists of CSMT
      using the Gonstead method. A specific contact, high velocity, low amplitude, short lever,
      with no recoil post adjustment directed to spinal biomechanical dysfunction diagnosed by
      standard chiropractic tests.

      Follow-up at 3, 6 and 12 months post-treatment. During this period participants continue to
      fill in a diagnostic headache diary. The control group will also be included in this phase of
      the study.

      The data will be analyzed with SPSS using standard statistical techniques.

      The investigators based our calculation of sample size on migraine days from recent group
      comparison studies of topiramate (38). The investigators calculated that a sample size of 16
      patients was required to detect a difference in mean reduction in monthly headache days of
      2.5 with 80% power, with p=0.05 as level of significance, and assuming a common SD of 2.5 for
      active treatment and broad-based treatment groups.

      Insurance is through "The Norwegian System of Compensation to Patients" (NPE) which is an
      independent national body, set up to process compensation claims from patients who have
      suffered an injury as a result of treatment under the Norwegian health service.

      The Regional Committee for Medical Research Ethics (REK) in Norway and Norwegian Social
      Science Data Services approved the full PhD research protocol. The declaration of Helsinski
      is followed.
    

Intervention name(s): Chiropractic; Sham Chiropractic
Intervention type(s): Other; Other
Intervention description(s): Chiropractic Spinal Manipulative Therapy; Sham manipulation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chiropractic; Manipulative therapy; Cervicogenic headache