Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care

Background. Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended. Objectives. Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain. Methods. A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2-12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs. Results. Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7-9.8] and SF-12 mental score (95% CI 2.7-10.7). At 6 months, this difference was no longer significant for EASPS (95% CI -1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0-9.9). Mean health care costs attributed to spinal pain were significantly greater by pound65 in the osteopathy group (95% CI pound32-pound155). Though osteopathy also cost pound22 more in mean total health care cost, this was not significant (95% CI -pound159 to pound142). Conclusion. A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach.