Twelve-month effect of chronic pain self-management intervention delivered in an easily accessible primary healthcare service - a randomised controlled trial

BACKGROUND: To investigate the effects after twelve months related to patient activation and a range of secondary outcomes on persons with chronic pain of a chronic pain self-management course compared to a low-impact outdoor physical activity, delivered in an easily accessible healthcare service in public primary care. METHODS: An open, pragmatic, parallel group randomised controlled trial was conducted. The intervention group was offered a group-based chronic pain self-management course with 2.5-h weekly sessions for a period of six weeks comprising education that included cognitive and behavioural strategies for pain management, movement exercises, group discussions and sharing of experiences among participants. The control group was offered a drop-in, low-impact, outdoor physical activity in groups in one-hour weekly sessions that included walking and simple strength exercises for a period of six weeks. The primary outcome was patient activation assessed using the Patient Activation Measure (PAM-13). Secondary outcomes included assessments of pain, anxiety and depression, pain self-efficacy, sense of coherence, health-related quality of life, well-being and the 30-s Chair to Stand Test. Analyses were performed using a linear mixed model. RESULTS: After twelve months, there were no statistically significant differences between the intervention group (n = 60) and the control group (n = 61) for the primary or the secondary outcomes. The estimated mean difference between the groups for the primary outcome PAM was 4.0 (CI 95% -0.6 to 8.6, p = 0.085). Within both of the groups, there were statistically significant improvements in pain experienced during the previous week, the global self-rated health measure and the 30-s Chair to Stand Test. CONCLUSIONS: No long-term effect of the chronic pain self-management course was found in comparison with a low-impact physical activity intervention for the primary outcome patient activation or for any secondary outcome. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02531282. Registered on August 212,015