Extrait

Background and study aims: 25,000 people in the UK have vertebral (spine) fractures related to their osteoporosis each year and many of these are referred for physiotherapy to help them recover after their fracture(s). Physiotherapy includes a variety of treatment options, such as exercise programmes or ‘hands on’ treatment like massage. At the moment there is some research evidence which suggests that physiotherapy may help to ease pain and help patients get back to their normal activities of daily life as soon as possible. However, we do not know which type of physiotherapy is most helpful to people, how much this treatment is costing the NHS, or what patients’ think of their treatment. The research question: Which type of physiotherapy helps patients with osteoporosis recover most after vertebral fracture? The study will test exercise and manual treatments and compare patients who have had these treatments to patients who have usual care with no physiotherapy treatment. The research will also provide information about treatment costs, safety and about what patients think about their treatment. Who can participate? Men and women with a diagnosis of primary osteoporosis confirmed by radiograph and with at least 1 painful vertebral fracture. Female participants will need to have passed menopause. All participants will have had appropriate fracture prevention therapy, be able to walk independently with or without an aid for at least 10 metres and be able to participate in a physiotherapy programme. What does the study involve? Participants will be asked to attend three assessments, the first before any treatment happens, the second 14 weeks later and the third twelve months after the study starts. After the first assessment a computer programme will decide which study group the person will join: treatment as usual, manual physiotherapy or exercise physiotherapy groups. Every participant will continue taking any osteoporosis medication, and will be offered education about osteoporosis and support through the trial with telephone calls every 2 months. In addition, the treatment groups will be offered 6 sessions of physiotherapy and asked to carry out some activities and exercises at home. What are the possible benefits and risks of participating? All participants will have access to usual care, and no treatment will be withheld from any participant. There is a slight risk that the treatments could increase pain or may lead to an increase in further fracture rates (25% fracture rates may be seen in the control group) and we will monitor these carefully. If the trial is successful, future patients will benefit from the clarification of the best treatment package for treating this condition. Alternatively, we may demonstrate that physiotherapy interventions are not effective for this condition, thus allowing National Health Service resources to be saved and redirected to other more effective treatments Where is the study run from? University of Oxford When is study starting and how long is it expected to run for? It is anticipated that recruitment will start early in 2013. Participants will be enrolled into the study for a period of 18 months; with follow up of patients for one year. In total the study will run for 4 years. Who is funding the study? NIHR Health Technology Assessment Programme Who is the main contact? Dr Karen Barker [email protected]

Critère d'inclusion

• Osteoporosis

Liens

• ictrp
• isrctn