A Supportive Self-Management Program for People With Chronic Headaches and Migraine: A Randomized Controlled Trial and Economic Evaluation
Underwood M., Achana F., Carnes D., Eldridge S., Ellard D., Griffiths F., Haywood K., Hee SW., Higgins H., Mistry D., Mistry H., Newton S., Nichols V., Norman C., Padfield E., Patel S., Petrou S., Pincus T., Potter R., Sandhu H., Stewart K., Taylor SJC., Matharu MS.
Background and Objectives:Chronic headache disorders are a major cause of pain and disability. Education and supportive self-management approaches could reduce burden of headache disability. We tested the effectiveness of a group educational and supportive self-management programme for people living with chronic headaches.Methods:A pragmatic randomised controlled trial. Participants were aged ≥18 years with chronic migraine or chronic tension type headache, with or without medication overuse headache.We primarily recruited from general practices. Participants were assigned to either a two-day group education and self-management programme, a one-to-one nurse interview, and telephone support or to usual care plus relaxation material.The primary outcome was headache related quality of life using the Headache Impact Test (HIT-6) at 12 months. The primary analysis used intention-to-treat principles for participants with migraine and both baseline and 12-month HIT-6 data.Results:Between April 2017 and March 2019, we randomised 736 participants. Since only nine participants just had tension type headache our main analyses were on the 727 participants with migraine. Of these 376 were allocated to the self-management intervention 351 to usual care. Data from 586 (81%) participants were analysed for primary outcome. There was no between group difference in HIT-6, (adjusted mean difference = -0·3, 95% CI -1·23 to 0·67), or headache days (0·9, 95% CI -0·29, 2·05), at 12 months. The CHESS intervention generated incremental adjusted costs of £268 (95% CI,£176 to £377) [USD383 (95%CI USD252 to USD539)] and incremental adjusted quality-adjusted life years (QALYs) of 0.031 (95% CI -0.005 to .063). The incremental cost-effectiveness ratio was £8,617 (USD12,322) per QALY gained.Discussion:These findings conclusively show a lack of benefit for quality of life or monthly headache days from a brief group education and supportive self-management programme for people living with chronic migraine or chronic tension type headache with episodic migraine.Registered on the International Standard Randomized Controlled Trial Number registry,ISRCTN7970810016th December 2015https://doi.org/10.1186/ISRCTN79708100The first enrolment was 24th April 2017.Classification of evidence:This study provides Class III evidence that a brief group education and self-management program does not increase the probability of improvement in headache related quality of life in people with chronic migraine.