Effectiveness of Mulligan manual therapy over exercise on headache frequency, intensity and disability for patients with migraine, tension-type headache and cervicogenic headache - a protocol of a pragmatic randomized controlled trial

Background: Non - pharmacological management of migraine, tension-type headache (TTH), and cervicogenic headache (CGH) may include spinal manual therapy and exercise. Mulligan Manual Therapy (MMT) utilizes a protocol of headache elimination procedures to manage headache parameters and associated disability, but has only been evaluated in CGH. There is little evidence for its effectiveness in migraine and TTH. This study aims to determine the effectiveness of MMT and exercise over exercise and placebo in the management of migraine, TTH, and CGH.

Methods: This pragmatic trial is designed as a prospective, three-armed randomised controlled trial in a clinical setting provided at a general hospital physiotherapy department. Two hundred ninety-seven participants with a diagnosis of migraine, TTH or CGH based on published headache classification guidelines will be included. An assessor blind to group allocation will measure outcomes pre-and post-intervention as well as 3 and 6 months after commencement of treatment. Participants will be allocated to one of the three groups: MMT and exercise; placebo and exercise; and exercise alone. The primary outcome measure is headache frequency. Secondary outcome measures are headache duration and intensity, medication intake, pressure pain threshold (PPT), range of motion recorded with the flexion rotation test, and headache disability recorded with Headache Activities of Daily Living Index (HADLI). The intention-to-treat principle will be followed for statistical analysis. Between groups differences for all outcome measures at baseline and at reassessment points and 95% confidence intervals will be calculated using a mixed model ANOVA. Post hoc tests will be conducted to identify any significant difference between groups and over time.

Discussion: This pragmatic study will provide evidence for the effectiveness of MMT when compared with a placebo intervention and exercise on headache frequency, intensity, and disability. Limitations are that baseline evaluation of headache parameters may be affected by recall bias. External validity will be limited to the population with a minimum 1-year history of headache. The HADLI is not yet extensively evaluated for its psychometric properties and association between PPT and headache parameters is lacking. Performance bias is inevitable as a single therapist will be delivering all interventions.

Trial registration: The trial was registered prospectively under the Clinical Trial Registry India (Registration number: CTRI/2019/06/019506 , dated on 03/06/2019). .