Every year, around 600 patients with broken spines caused by osteoporosis will be randomly assigned to manual therapy, exercise classes, or standard care to settle a long-running dispute about which treatment works best. Doctors and physiotherapists do not agree on the best way to help people whose vertebrae have collapsed under the weight of fragile bone. Some argue that hands-on mobilisation relieves pain and improves movement; others insist that targeted strengthening exercises are safer and more effective. Without a large, rigorous trial, clinicians have no reliable evidence to guide their decisions, and patients may receive treatments that are ineffective or even harmful. If the trial identifies a clear winner—or rules out an ineffective approach—NHS physiotherapy services will have a definitive protocol to follow. That means fewer patients left in unnecessary pain, less time wasted on treatments that do not work, and better value for the health service. The results will directly shape clinical guidelines for one of the most common and debilitating fractures in older adults.
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Uncertainty exists regarding the best physiotherapeutic interventions to use with patients with vertebral osteoporotic fracture. Design: a prospective, multi-centred adaptive randomised controlled trial with three arms and blinded outcome assessment. Measures at baseline (0 months), post intervention (week 12) and 12 months. Participants will be randomised to control (A), manual (B) or exercise (C) interventions. An interim analysis at 3 months will be completed and if one intervention is clearly ineffective the trial will then be adapted to a two arm trial. A qualitative study using an interpretative phenomenological analysis (IPA) approach will be incorporated to explore experiences and views regarding the interventions. The trial will be preceded by an intervention development phase that includes a systematic review and pilot study. Settings: 10 centres Measurement of costs and outcomes: We will confirm diagnosis of osteoporosis and fracture through either radiographs, MRI or DXA. The primary outcome will be quality of life (QoL) as measured by the disease specific QUALEFFO 41 questionnaire. Pain will be measured using a 10 point VAS and the EQ5D will be used to evaluate health economics. We will measure kyphosis using a flexicurve ruler, strength with the Timed Loaded Standing (TLS) test, balance (proprioception) with the Short Physical Performance Battery (SPPB) and Functional Reach Tests (FRT), functional mobility and activity with the SPPB, a 6 minute walk and the Physical Activity Scale for the Elderly (PASE) questionnaire. Sample size: The initial sample size calculation is based on a traditional approach to a 3 arm trial. We wish to detect a standardised effect of 0.4 in the QUALEFFO; at 80% power and an alpha of 0.05 we would require 600 patients to be recruited
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