Effectiveness of Manual Therapy as an Adjunct to Care as Normal in Female Chronic Migraine Patients. A Randomised Controlled Trial

Abstract

Abstract Background and purpose The aim of this study was to explore the effectiveness of manual therapy as an adjunctive treatment to usual care in females severely affected with chronic migraine. Methods This was a pragmatic, randomised controlled trial (RCT) in a tertiary headache clinic in the UK. Sixty-four female participants with severe chronic migraine were randomised into two groups: Onabotulinum A (Botox TM) and Botox TM with manual therapy. The Botox TM was given to both groups at the start on a 12-week schedule. The manual therapy was a combination of mobilisation, manipulation and soft tissue release technique and was given 5 times over 12 weeks. The RCT consisted of 3 months intervention with primary outcome measures taken at the end of the study period. The primary outcome was the between-group difference in change scores using the Headache Impact Test (HIT6). Secondary outcomes were Patient Global Impression of Change (PGIC) and responder rates. Results The primary outcome favoured the use of manual therapy as an adjunct to usual tertiary care over usual tertiary care (BotoxTM)alone with a significant difference in between-group HIT6 change scores (p=0.006, d=0.51) The manual therapy group also had significantly more responders based on HIT6 (p=0.006) and PGIC (p= 0.002) outcomes. Conclusions This study has found that manual therapy is an effective adjunct to the usual tertiary care (BotoxTM) of chronic migraine in women. Trial Registration The trial received a favourable opinion from the UK Health Research Authority (IRAS 228901) and is registered at ClinicalTrials.gov.number NCT03395457. Registered 1st March 2018.