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

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

Pain neuroscience education and physical exercise for patients with chronic spinal pain in primary healthcare: a randomised trial protocol

Background: Chronic musculoskeletal pain affects more than 20% of the population, and the prevalence is increasing, causing suffering, loss of quality of life, disability, and an enormous expenditure on healthcare resources. The most common location for chronic pain is the spine. Many of the treatments used are mainly passive (pharmacological and invasive) and poor outcomes. The treatments currently applied in the public health system do not comply with the recommendations of the main clinical practice guidelines, which suggest the use of educational measures and physical exercise as the first-line treatment. A protocol based on active coping strategies is described, which will be evaluated through a clinical trial and which could facilitate the transfer of the recommendations of the clinical practice guidelines to a primary care setting. Methods: Randomised and multicentre clinical trials, which will be carried out in 10 Primary Care centres. The trial will compare the effect of a Pain Neuroscience Education program (six sessions, 10 h) and group physical exercise (18 sessions program carried out in six weeks, 18 h), with usual care physiotherapy treatment. Group physical exercise incorporates dual tasks, gaming, and reinforcement of contents of the educational program. The aim is to assess the effect of the intervention on quality of life, as well as on pain, disability, catastrophism, kinesiophobia, central sensitisation, and drug use. The outcome variables will be measured at the beginning of the intervention, after the intervention (week 11), at six months, and a year. Discussion: Therapeutic interventions based on active coping strategies are essential for the treatment of chronic pain and the sustainability of the Public Health System. Demonstrating whether group interventions have an effect size is essential for optimising resources in such a prevalent problem. Trial registration: NCT03654235 "Retrospectively registered" 31 August 2018.The clinical trial that has allowed the development of the present protocol has been made possible thanks to the funding received from the Regional Health Management of Castilla y León and the Professional College of Physiotherapists of Castilla y León.Ye