The effectiveness and efficiency of a primary care based osteopathy clinic for spinal pain

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

Understanding sciatica: illness and treatment beliefs in a lumbar radicular pain population. A qualitative interview study.

BACKGROUND:Several pathological processes contribute to lumbar radicular pain (LRP), commonly known as sciatica. It is not known how patients rationalise the experience of sciatica or understand the diagnosis. Providing clinicians with a better understanding of how patients conceptualise sciatica will help them to tailor information for patients on the management and treatment of the condition. AIM:To understand patients' beliefs regarding their illness following a diagnosis of LRP, how these beliefs were developed, and the impact of illness beliefs on treatment beliefs. DESIGN & SETTING:Qualitative interview study from a single NHS musculoskeletal interface service (in Wales, UK). METHOD:Thirteen patients recently diagnosed with LRP were consecutively recruited. Individual semi-structured interviews were recorded and transcribed. Data were analysed using a thematic approach. RESULTS:Four main themes were generated: (1) the illness experience (2) the concept of sciatica, (3) treatment beliefs, and (4) the desire for credible information. CONCLUSION:The diagnosis of LRP is often communicated and understood within a compressive conceptual illness identity. Explaining symptoms with a compressive pathological model is easily understood by patients but may not accurately reflect the spectrum of pathological processes known to contribute to radicular pain. This model appears to inform patient beliefs about treatments. Clinicians should take care to fully explain the pathology prior to shared decision-making with patients

Health professionals' perspectives on exercise referral and physical activity promotion in primary care: Findings from a process evaluation of the National Exercise Referral Scheme in Wales.

Background and objectives: Referring clinicians’ experiences of exercise referral schemes (ERS) can provide valuable insights into their uptake. However, most qualitative studies focus on patient views only. This paper explores health professionals’ perceptions of their role in promoting physical activity and experiences of a National Exercise Referral Scheme (NERS) in Wales. Design: Qualitative semi-structured group interviews. Setting: General practice premises. Methods: Nine semi-structured group interviews involving 46 health professionals were conducted on general practice premises in six local health board areas. Purposive sampling taking into account area deprivation, practice size and referral rates was employed. Interviews were transcribed verbatim and analysed using the Framework method of thematic analysis. Results: Health professionals described physical activity promotion as important, although many thought it was outside of their expertise and remit, and less important than other health promotion activities such as smoking cessation. Professionals linked decisions on whether to advise physical activity to patients to their own physical activity levels and to subjective judgements of patient motivation. While some described ERS as a holistic alternative to medication, with potential social benefits, others expressed concerns regarding their limited reach and potential to exacerbate inequalities. Barriers to referral included geographic isolation and uncertainties about patient selection criteria, medico-legal responsibilities and a lack of feedback about patient progress. Conclusion: Clinicians’ concerns about expertise, priority setting and time constraints should be addressed to enhance physical activity promotion in primary care. Further research is needed to fully understand decision making relating to provision of physical activity advice and use of ERS

Protocol for a definitive randomised controlled trial and economic evaluation of a community-based rehabilitation programme following hip fracture:fracture in the elderly multidisciplinary rehabilitation-phase III (FEMuR III)

Introduction: Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.  Methods and analysis: Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks' follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.  Ethics and dissemination: National Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.  Trial registration number ISRCTN28376407; Pre-results registered on 23 November 2018

Randomised osteopathic manipulation study (ROMANS): a 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 £65 in the osteopathy group (95% CI £32–£155). Though osteopathy also cost £22 more in mean total health care cost, this was not significant (95% CI ?£159 to £142). 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