Classical Massage and Acupuncture in Chronic Back Pain - Non-Inferiority Randomised Trial.

Background: Currently, there is a need for scientific evidence on the efficacy of classical massage therapy for chronic, unspecific back pain, especially for the improvement in functional impairment and long-term pain reduction. According to the National Health Care Guidelines, classical massage for nonspecific low back pain may only be prescribed in combination with exercise therapy and a share of the remuneration. Acupuncture, on the other hand, is recognised in the guidelines as an independent treatment for chronic back pain and is remunerated by health insurance companies. This raises the question of whether classical massage therapy is not inferior compared to acupuncture, based on the therapy of the GERAC study. The Clinic of Naturopathy in Blankenstein, Hattingen uses classical massage therapy subjectively successfully in patients with back pain. To objectify the success of the treatment, a randomised controlled, non-inferiority study was conducted.

Methods: The efficacy of classical massage (KMT, n = 66) was compared with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain ("Von Korff"-Questionnaire) at the follow-up after one month.

Results: In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).

Conclusions: The results show that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.