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Exercise and self-management for people with chronic knee, hip or lower back pain: a cluster randomised controlled trial of clinical and cost-effectiveness. Study protocol

Research output: Contribution to journalJournal article

Published

  • Nicola Walsh
  • Fiona Cramp
  • Shea Palmer
  • Jon Pollock
  • Lisa Hampson
  • Rachel Gooberman-Hill
  • Colin Green
  • Louise Jones
  • Sonia Phillips
  • Liz Johnson
  • Mike Hurley
Journal publication date12/2013
JournalPhysiotherapy
Journal number4
Volume99
Number of pages6
Pages352-357
Early online date30/11/12
Original languageEnglish

Abstract

Objectives
Chronic musculoskeletal pain and osteoarthritis can significantly limit the functional independence of individuals, and given that 25% of the population experience these problems, the socioeconomic impact is immense. Exercise and self-management have proven benefits for these conditions, but most trials tailor interventions for specific joints. Epidemiological data demonstrates that many older people with degenerative joint problems experience pain and functional difficulty in other joints, seeking further healthcare input when these present. Managing multiple joint presentations simultaneously could potentially reduce the need for repeat visits to healthcare professionals as advice is frequently the same for differing site presentations. This single-blind cluster randomised controlled trial will determine the clinical and cost-effectiveness of an exercise and self-management intervention delivered to people over-50 with either hip, knee or lower back pain, compared to ‘standard’ GP care. A qualitative analysis will also establish the acceptability of the intervention.

Methods
352 people with chronic degenerative musculoskeletal pain of the hip, knee or lower back will be recruited from primary care. GP surgeries will be randomised to either the intervention or control arms. Participants in the intervention arm will receive a 6-week group exercise and self-management programme facilitated by a physiotherapist in primary care. Participants allocated to the control arm will continue under ‘standard’ GP care. The primary outcome measure is the Dysfunction Index of the Short Musculoskeletal Functional Assessment (SMFA).

Analysis
Individual patient responses will be modelled using a mixed effects linear regression, allowing for the clustering effects. Resource use and related intervention costs will be estimated and broader resource use data will be collected using a version of the Client Service Receipt Inventory adapted for musculoskeletal relevance. In addition, a cost-utility analysis will be undertaken to present an estimate of the incremental cost per QALY. A qualitative analysis investigating the acceptability of the intervention to participants and healthcare professionals will also be undertaken and thematically analysed.

Ethics and dissemination
Ethical approval was received from South West 4 REC, identification number 11/SW/0053. Study findings will be disseminated via conference and journal presentation; via arthritis charitable organisations; and through local GP consortia.