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 randomised controlled trial

Background: Chronic neck and shoulder region pain affects many people around the world. This study aims to compare the effectiveness of three 8-week meditation training programmes (each using a different meditation technique: Anapana, Body scan or Metta) on pain and disability in a patient population affected with chronic neck and shoulder region pain, with a usual care control group and with each other. Methods: This four-arm parallel 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 single 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 primary (differences in changes in pain (Numeric Pain Rating Scale) at 8 weeks) and secondary (differences in changes in pain, physical disability, range of movement and quality of life (SF-36) at 4 and 12 weeks) outcomes between groups, a two-way ANOVA will be used if data are normally distributed. If data are 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 is a four-arm trial which describes how three different 8-week meditation technique (Anapana, Body Scan, Metta) interventions will be implemented with adult patients affected with chronic neck and shoulder region pain. The effectiveness of each meditation intervention on the pain, physical and psychosocial disabilities of patients will be compared between groups and with a usual care control group. The results of this study will contribute to recommendations for future meditation interventions for chronic neck and shoulder pain. Trial registration: ISRCTN12146140. Registered on 20 August 2021.