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Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_9 | Pages 14 - 14
1 Oct 2022
Williamson E Boniface G Marian I Dutton S Maredza M Petrou S Garrett A Morris A Hansen Z Ward L Nicolson P Barker K Fairbank J Fitch J Rogers D Comer C French D Mallen C Lamb S
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Purpose and background. To evaluate the clinical and cost-effectiveness of a physical and psychological group intervention (BOOST programme) compared to physiotherapy assessment and advice (best practice advice [BPA]) for older adults with neurogenic claudication (NC) which is a debilitating spinal condition. Methods and results. A randomised controlled trial of 438 participants. The primary outcome was the Oswestry Disability Index (ODI) at 12 months. Data was also collected at 6 months. Other outcomes included Swiss Spinal Stenosis Questionnaire (symptoms), ODI walking item, 6-minute walk test (6MWT) and falls. The analysis was intention-to-treat. We collected the EQ5D and health and social care use to estimate cost-effectiveness. Participants were, on average, 74.9 years old (SD 6.0). There was no significant difference in ODI scores between groups at 12 months (adjusted mean difference (MD): −1.4 [95% Confidence Intervals (CI) −4.03,1.17]), but, at 6 months, ODI scores favoured the BOOST programme (adjusted MD: −3.7 [95% CI −6.27, −1.06]). Symptoms followed a similar pattern. The BOOST programme resulted in greater improvements in walking capacity (6MWT MD 21.7m [95% CI 5.96, 37.38]) and ODI walking item (MD −0.2 [95% CI −0.45, −0.01]) and reduced falls risk (odds ratio 0.6 [95% CI 0.40, 0.98]) compared to BPA at 12 months. Probability that the BOOST programme is cost-effective ranged from 67%–89% across cost-effectiveness thresholds. Conclusions. The BOOST programme improves mobility and reduces falls in older adults with NC compared to BPA at 12 months follow-up. It is good value for the NHS. Future iterations of the programme will consider ways to reduce symptoms and disability long-term. Conflicts of interest: No conflicts of interest. Sources of funding: National Institute of Health Research – Programme for Applied Research NIHR - PTC-RP-PG-0213-20002: Better Outcomes for Older people with Spinal Trouble (BOOST). Publication and presentations: The clinical effectiveness paper has just been accepted for publication in the Journal of Gerontology Series A. The health economic analysis is not yet published. It was presented at the Physiotherapy UK conference and the International Back and Neck Pain Forum in 2021


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims

Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS).

Methods

UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 28 - 28
1 Feb 2014
Newsome R Reddington M Breakwell L Chiverton N Cole A Michael A Boote J Dimairo M
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Purpose of study and background. The primary aim of the study was to test the feasibility of conducting a full RCT with economic analysis and help to inform the provision of physiotherapy in a specific sub-group of patients with sciatica. Methods. 60 patients waiting for primary, unilateral, single level, lumbar micro-discectomy surgery were recruited and randomised into two groups. The intervention group received a new spinal physiotherapy regimen. Primary outcome measure was the number of patients who did not require surgery at the time of consent clinic. Secondary measures were the Visual Analogue Scale (VAS) Oswestry Disability Index (ODI) and EQ5DL, taken at recruitment, 1 week before surgery and 2 weeks and 3 months after surgery. Results. 1 week before surgery, 3 patients of 30 (10.0%) in the non-physiotherapy group and 5 out of 29 (17.2%) in the physiotherapy group did not require surgery translating into a difference of −7.2% (95%CI-25.7% to 11.1%) in favour of the physiotherapy group but not statistically significant. All the secondary outcome measures demonstrated that patients in the physiotherapy group had a greater improvement but this was not statistically significant due to the small trial numbers. Conclusion. This study informs the feasibility of planning of a large RCT with regard to recruitment, adherence to treatment and outcome measures. The observational data shows that physiotherapy can have a positive impact on these patients with sciatica which diminishes with time. These results provide a framework for further studies. This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0110-21158). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health