Effectiveness of Anapana, Body scan and Metta meditation techniques on chronic neck and shoulder region pain and disability in adult patients in Sri Lanka.: study protocol for a cluster clinic-level parallel randomised controlled trial

Background Chronic neck and shoulder region pain affects many people in the world. This study aims to compare the effectiveness of an eight-week training programme on pain and disability in a patient population affected with chronic neck and shoulder region pain, using Anapana, Body Scan and Metta meditation techniques, with a usual care control group and with each other. Methods This parallel cluster clinic-level randomised controlled trial will be conducted with male and female patients aged 18-65 years, who are affected with chronic neck and shoulder region pain, and who attend one of four clinics held on four different days of the week in a medical centre in the Colombo North region, Sri Lanka. Clinics will be considered as clusters and randomly allocated to intervention and control arms. Data will be collected using validated questionnaires, clinical examinations and focus groups. To compare baseline with primary (differences in changes in pain at 8 weeks) and secondary outcomes (differences in changes in pain, physical disability, range of movement and quality of life at 4 and 12 weeks), a two-way ANOVA will be used if the data is normally distributed. If the data is not normally distributed a nonparametric equivalent (Kruskal Wallis) will be used. Focus group transcriptions will be thematically analysed using the Richie and Spencer model of qualitative data analysis. Discussion                                                                                             This protocol describes how three meditation interventions will be implemented on the management of patients affected with chronic neck and shoulder region pain and compared with a usual care control-group. The effectiveness of each meditation intervention on the pain, physical and psychosocial disabilities of patients will be compared between groups. The results of this study will enable recommendations to be made for future meditation interventions for chronic neck and shoulder pain. Trial Registration ISRCTN12146140 Date of registration : 20/08/2021 (https://www.isrctn.com/ISRCTN12146140).