Manual therapy for chronic migraine: A pragmatic randomised controlled trial study protocol

Introduction: Chronic migraine is a largely refractory condition affecting between 1-2.2% of the overall population worldwide, with females more affected than males. There are also high health and socioeconomic costs associated both for the individual and society. The mainstay of chronic migraine management is pharmacological, but the options available have limited efficacy and there are often unwanted side effects. There is some evidence for manual therapy as a treatment option for migraine, but its effectiveness for chronic migraine is unknown. Therefore, we have designed a pragmatic randomised control trial to investigate whether adding manual therapy to the tertiary specialist treatment of chronic migraine improves patient-reported outcomes. Methods: A pragmatic, randomised controlled trial in a hospital tertiary headache clinic. Participants will be randomised into one of two groups: treatment as usual or treatment as usual plus manual therapy. The primary outcome measure will be a change in the Headache Impact Test score. Secondary outcomes will also be measured over the 12-week study period including changes in headache frequency, migraine specific quality of life and reductions in relevant medicine consumption. The manual therapy group will have five treatment sessions each lasting 30 minutes. The recruitment target of 64 participants will allow power at 80% with p=0.05 using minimal clinical difference for Headache Impact Test of 3.7 and includes provision for a 10% dropout rate. Recruitment will take place between August 2018 and March 2019. The results will form part of a doctoral study and be published in peer-reviewed journals and presented at national/international conferences. Discussion: Current pharmacological approaches have limited effects in the management of chronic migraine and there is a requirement to improve treatment options and reduce the health and economic burden of the condition. Manual therapy has been shown to be effective in other chronic pain conditions as well as other primary headaches. This study will explore the effectiveness of manual therapy as an adjunctive approach to the management of chronic migraine.

Journal Ref. Odell
Intervention Other - Manual Therapy - Mobilization, manipulation and soft tissue techniques
Number of sites 1
Countries involved UK
Sample size 64
Type of statistical analyses Descriptive, Manova, student T,Correlation, Linear Regression
Risk of bias Overall: Low Risk details
Participant characteristics Age: 18 or over
Condition: Chronic Migraine
Baseline severity: Severe
Duration of trial 3 months
Primary outcome Change in Headache Impact Test
Show Score Ranges


(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
5 5 5 4 5 3 4 5 3