Unpublished PhD thesis, Cardiff University, 2004/10, 528, type of study: ,rct,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,

Free full text   (https://orca.cardiff.ac.uk/id/eprint/55572/)

Keywords:

OMT [3924]
osteopathic manipulative treatment [3945]
primary care [68]
randomized controlled trial [947]
spinal pain [5]
Wales [5]

Abstract:

Spinal pain is common, disabling, costly to society, and a frequent reason for consulting a general practitioner (GP). Usual GP care involves the prescription of analgesia, advice about rest, activity and work, and orthopaedic or physiotherapy referral. Spinal manipulation is recommended by low back pain clinical guidelines, but recent Cochrane reviews found that manipulation has limited effectiveness compared with other treatments, although few trials comparing spinal manipulation with usual GP care were identified. A primary care osteopathy clinic was established in Llanfairfechan health centre by the author. The overall aims of this thesis were to determine whether this was more effective than usual GP care, and an efficient use of health service resources. Preparatory studies comprised an audit of the clinic to describe the treatment package, development of a set of condition-specific outcome measures for the whole spine, the Extended Aberdeen Spinal Pain Scales (EASPS), and their psychometric testing, as well as piloting other secondary outcome measures. The Randomised Osteopathic MANipulation Study (ROMANS) recruited 199 patients randomised to usual GP care, or an additional three sessions of osteopathic spinal manipulation. After two months all outcome measures had improved in both groups the osteopathic treatment group by more than the usual care group. This improvement was significantly greater in the primary outcome measure the EASPS (effect size 0.4) and the SF-12 mental score (effect size 0.6). At six months most outcome measures had continued to improve in both groups, and the improvement in the osteopathy group remained significantly greater for the mental score of the SF-12 (effect size 0.5) but not for the EASPS. The point estimate of the cost per improvement in QALY gain was less than £4,000. When these results were combined in a meta-analysis with similar trials, manipulation was significantly more effective. Compared to usual GP care spinal manipulation is an effective and efficient use of health service resources.