Complementary, integrative, and standard rehabilitative therapies in a military population with chronic predominantly musculoskeletal pain: a pragmatic clinical trial with SMART design

There is growing acceptance for combining complementary and integrative health (CIH) therapies with standard rehabilitative care (SRC) for chronic pain management, yet little evidence on the best sequence of therapies. We investigated whether starting with CIH therapies or SRC is more effective in reducing pain impact. Participants were 280 service members with predominantly (88%) musculoskeletal chronic pain referred to an interdisciplinary pain management center who were randomized to a twice weekly program of either CIH therapies (n = 140) or SRC (n = 140) for the 3-week first stage of treatment. The composition of a second 3-week treatment stage depended upon response to the first stage. The primary outcome measure was the impact score (range 8-50) from the NIH Task Force on Research Standards for Chronic Low-Back Pain. Outcomes were measured after 3 and 6 weeks of treatment and at 3- and 6-month follow-ups. Most participants were men (76.8%) and mean age was 34.7 years (SD 8.0). At end of stage 1, pain impact decreased significantly more in the CIH group (29.8 points [SD 7.2] at baseline to 26.3 points [SD 7.9], change of -3.3 points [95% confidence interval, -4.2 to -2.5]) than in the SRC group (30.8 [SD 7.6] to 29.4 [SD 7.8], change of -0.9 points [95% confidence interval, -1.8 to -0.1]; P < 0.001). No significant between-group differences were observed after 6 weeks of treatment nor at 3- or 6-month follow-ups. Complementary and integrative health therapies may provide earlier improvement in pain impact than SRC, but this difference is not sustained.