Maintained physical activity and physiotherapy in the management of distal upper limb pain – a protocol for a randomised controlled trial (the Arm Pain Trial)

Background

Upper limb pain is a common cause of disability, demand for health care and lost work time. It is more likely to become persistent if it is accompanied by poor mental health, tendency to somatise, and negative beliefs concerning health and activity. Consequently response to treatment may vary between subgroups defined by such characteristics. Distal upper limb pain (affecting the elbow, forearm, wrist, or hand) can result from several specific musculoskeletal disorders, or be non-specific. Although it is clinically important and costly, the best approach to its clinical management is unclear. Physiotherapy and advice to rest and avoid strenuous activities are often given, but there is no evidence base to support these strategies. Indeed, consistent with evidence on back pain, advice to rest the painful limb may even be inferior to advice to remain active. The purpose of this randomised controlled trial is therefore to explore whether in patients awaiting physiotherapy for distal upper limb pain, advice to maintain activities produces a long-term reduction of symptoms and disability compared with advice to rest. The pragmatic nature of this trial also provides an opportunity to test whether immediate physiotherapy is more beneficial than physiotherapy received after the normal waiting time. Currently waiting times vary between centres, and over time, but 7-10 weeks is not uncommon.

Methods / Design

555 patients with distal upper limb pain are being recruited from out-patient physiotherapy departments and randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Interventions are of 6 weeks duration, after which physiotherapy is offered to the two advice groups at the time it would normally be received. Patients are assessed at baseline and followed up at 6, 13, and 26 weeks post-randomisation by self-completed postal questionnaire. The primary outcome is the proportion of patients free of disability at the 26 week time point, as determined by the modified-DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. A secondary outcome for patients randomised to the two advice groups is the proportion who seek physiotherapy at 6 weeks. Other secondary outcomes include upper limb pain and function, coping, fear of movement, ability to function at work, and aspects of general health and quality of life.

Analysis

We hypothesise (a) that patients who are advised to maintain usual activities while waiting to receive physiotherapy will experience long-term improvements in function compared to those advised to rest the arm; and (b) patients who receive fast-track physiotherapy will experience long-term improvements in function compared to those who receive physiotherapy at the normal time. These hypotheses will be examined using an intention-to-treat analysis.

Discussion

Results from this trial will contribute to the evidence base underpinning the clinical management of patients with distal upper limb pain, and in particular whether they should be advised to rest the arm or remain active within the limits imposed by their symptoms.