Extrait

Background and study aims Tactile acuity (the keenness of the sense of touch) can be measured using the two-point discrimination test. This is the minimal distance between two points that can be detected on the skin surface. Tactile acuity is poor in patients with chronic pain conditions such as chronic regional pain syndrome and phantom limb pain (the sensation of pain in a limb that is missing/amputated). Tactile acuity training in these conditions can improve tactile acuity and, more importantly, it can reduce pain. The reduction in pain is strongly related to improvement in tactile acuity. Patients with chronic low back pain have poor tactile acuity. However, it is not known if tactile acuity training will improve pain and functioning in this patient group. The main aim of this study was to investigate the how well tactile acuity training worked on pain and function for patients with persistent low back pain. The secondary aim of this study was to investigate how well tactile acuity training works on tactile acuity performance for patients with persistent low back pain. Tactile acuity training has previously required considerable amounts of patient-therapist contact e.g. 30 minutes daily for two to three weeks. This level of contact may not be practical within the current NHS structure. As such, the intervention within this study had a large home exercise component delivered by an informal carer (friend/relative). Another aim of this study was to find out what patients and informal carers thought of the home exercise part of the intervention. Who can participate? Participants were individuals ≥18 years of age with chronic low back pain and their informal carer. What does the study involve? Participants were randomly divided into two groups: the intervention group who received usual care physiotherapy and tactile acuity training or the placebo group who will receive usual care physiotherapy and placebo training. Tactile acuity training involved two types of training: five point discrimination training and graphaesthesia training. In the former, five areas of the back are stimulated using either a pen top or a wine bottle cork. The participant provides feedback as to which area was stimulated and whether the pen top or bottle cork was used. The carer will then say if the patient was correct or not. In the graphaesthesia test, 60 letters would be traced onto the patient’s back using the carers’ finger and the patient asked to guess which letter was drawn. The carer then says if the patient was correct or not. The placebo training involves skin stimulation but no effort by the patient to describe what is happening e.g. they provide no feedback to the carer and vice versa. Tactile acuity/placebo training involved three training sessions with a physiotherapist in the first two weeks of usual physiotherapy care. The remaining sessions were delivered as part of a home training package delivered by the informal carer (friend/relative). Participation in the study lasted as long as usual care physiotherapy which was decided by the treating therapist (usually four to six weeks). Additionally, participants along with their informal carers were asked to take part in a focus group once all participants had completed their treatment. In this focus group we explored the attitudes of participants and their carers towards the intervention. What are the possible benefits and risks of participating? The risks associated with this study were minor. The likelihood of harm was low and the consequences would be small. Previous research using a very similar intervention and placebo group reported no adverse effects or risks and direct email correspondence with previous authors have confirmed this. It was possible that the informal carers (friend/relative) would undergo some degree of psychological stress as a result of having to deliver the home training package. Arguably, an individual who is likely to be stressed by this was unlikely to volunteer. However, the informal carer received a high standard of training and support and the fact that no adverse effects or side effects were previously reported was emphasised. It was also emphasised that the informal carer could withdraw from the study at any time, without giving a reason, with no consequences. These measures should have helped to reduce any undue stress. Where is the study run from? The study was run from the Physiotherapy Department at the Friarage Hospital, Northallerton, UK. When is study starting and how long is it expected to run for? The study ran from February 2012 to January 2013. Who is funding the study? The study was funded by the Teesside University Research Fund administered by Teesside University (UK). Who is the main contact? Dr Nicholas Harland PhD [email protected] Dr Cormac Ryan PhD [email protected]

Critère d'inclusion

• Chronic Low Back Pain

Liens

• isrctn
• ictrp