Abstract
Cervicogenic headache (CEH) is a secondary headache which affects 1.0–4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for CEH in a single-blinded placebo-controlled randomized clinical trial (RCT). According to the power calculations, we aim to recruit 120 participants to the RCT. Participants will be randomized into one of three groups; CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of intervention and 3, 6 and 12 months. Primary end-point is headache frequency, while headache duration, headache intensity, headache index (frequency × duration × intensity) and medicine consumption are secondary end-points. Primary analysis will assess a change in headache frequency from baseline to the end of intervention and to follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Due to two group-comparisons, the results with p values below 0.025 will be considered statistically significant. For all secondary end-points and analyses, the significance level of 0.05 will be used. The results will be presented with the corresponding p values and 95 % confidence intervals. To our knowledge, this is the first prospective manual therapy three-armed single-blinded placebo-controlled RCT to be conducted for CEH. Current RCTs suggest efficacy in headache frequency, duration and intensity. However a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings. The present study design adheres to the recommendations for pharmacological RCTs as far as possible and follows the recommended clinical trial guidelines by the International Headache Society.Trial registration ClinicalTrials.gov identifier: NCT01687881, 2 December 2012
Highlights
The prevalence of cervicogenic headache (CEH) is low and varies from 1.0 to 4.6 % in the general population, depending on the applied diagnostic criteria, i.e. 1.0 % if 6 and 4.6 % if 5 diagnostic criteria of the CervicogenicHeadache International Study Group are fulfilled, and 2.5 % if the criteria of the International Headache Society (IHS) are applied (Table 1) (Nilsson 1995a; Pareira Monteriro 1995; Sjaastad et al 1998; Sjaastad and Bakketeig 2008; Headache Classification Subcommittee of the International Headache Society 2013)
Our primary hypothesis is that chiropractic spinal manipulative therapy (CSMT) gives at least 25 % reduction in average number of headache days per month (30 days) as compared to no change in the placebo and the control group from baseline to the end of intervention, and we expect the same reduction to maintain at 3, 6 and 12 months follow-up
If the CSMT treatment is effective, it will be offered to participants whom received placebo or control after study completion, i.e., after 12 months follow-up
Summary
The prevalence of cervicogenic headache (CEH) is low and varies from 1.0 to 4.6 % in the general population, depending on the applied diagnostic criteria, i.e. 1.0 % if 6 and 4.6 % if 5 diagnostic criteria of the CervicogenicHeadache International Study Group are fulfilled, and 2.5 % if the criteria of the International Headache Society (IHS) are applied (Table 1) (Nilsson 1995a; Pareira Monteriro 1995; Sjaastad et al 1998; Sjaastad and Bakketeig 2008; Headache Classification Subcommittee of the International Headache Society 2013). The prevalence of cervicogenic headache (CEH) is low and varies from 1.0 to 4.6 % in the general population, depending on the applied diagnostic criteria, i.e. 1.0 % if 6 and 4.6 % if 5 diagnostic criteria of the Cervicogenic. Headache disorders have substantial health and socio-economic costs (Vos et al 2012). No studies have exclusively investigated the costs for CEH. Symptoms and signs of neck involvement a. By neck movement and/or sustained awkward head positioning, and/or: ii. Restriction of range of motion (ROM) in the neck c. Ipsilateral neck, shoulder, or arm pain of a rather vague nonradicular nature or, occasionally, arm pain of a radicular nature
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