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

Jim Odell, Carol Clark, Adrian Hunnisett, Osman Hassan Ahmed, Jonathan Branney, Jim Odell, Carol Clark, Adrian Hunnisett, Osman Hassan Ahmed, Jonathan Branney

Abstract

Introduction: Chronic migraine is a largely refractory condition affecting between 1 and 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 min. 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 February 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.

Trial registration: The trial has received a favourable opinion from the UK Health Research Authority (IRAS 228901) and is registered at ClinicalTrials.gov.number NCT03395457. Registered 1st March 2018.

Keywords: Allodynia; Chiropractic; Chronic migraine; Headache; Manual therapy; Randomised controlled trial.

Conflict of interest statement

The study has been approved the UK Heath Research Authority, Bournemouth University ethics panel, and R&D at Salford Royal NHS Foundation Trust (IRAS 228901). The declaration of Helsinki will be adhered to during this study. All data will be anonymised and participants must provide written informed consent. Insurance is provided through Bournemouth University. The procedure for withdrawal from the study is in line with the HRA non CITMP study protocol. Severe adverse events reported to the CI or the neurologists and will result in their withdrawal and appropriate referral to their General practitioner or neurologist. The study may be monitored in accordance with SRFT’s R &D department. Standard operating procedures, to ensure compliance with GCP and the Research Governance Framework 2005. All trial related documents will be made available upon request for monitoring by R&D monitors. Any changes to the protocol will be communicated as per the HRA guidelines.Not applicableThe authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow

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