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Williams MA, Williamson EM, Heine PJ, et al.; on behalf of the SARAH trial group. Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation. Southampton (UK): NIHR Journals Library; 2015 Mar. (Health Technology Assessment, No. 19.19.)

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Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH). A randomised controlled trial and economic evaluation.

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Chapter 1Introduction

Background

Epidemiology of rheumatoid arthritis

Rheumatoid arthritis (RA) is the most common inflammatory polyarthritis.1 It is a chronic unpredictable disorder that can cause persistent joint pain, joint damage and long-term disability (especially in the hands and feet). The prevalence of RA is 1.16% in women and 0.44% in men, increasing with age to 5% in those aged over 55 years.1 It affects approximately 1% of the UK adult population. Five years after diagnosis, 40% of people with RA have relatively normal function (13% in remission), 44% have mild to moderate disability and 16% have marked functional disability.2 The cause of the disease is unknown but both environmental and genetic factors are believed to contribute.

Rheumatoid arthritis is a whole-body disorder with greater mortality and multisystemic effects. The condition usually starts in the small joints of the hands and feet and later spreads to involve the larger joints. T-cells infiltrate the synovium, resulting in hypertrophy and inflammation of the local area and supporting ligaments. Deformities arise as a result of joint cartilage being eroded, which can then extend into the bone cortex. There are common forms of deformities at the wrist (dorsal ulnar head subluxation),3 metacarpophalangeal (MCP) joints (volar subluxation of proximal phalanges and ulnar drift of fingers), fingers (swan-neck and boutonnière deformities) and thumb [instability at the MCP and interphalangeal (IP) joints]. Tendon rupture can occur as a result of weakening by synovial invasion or abrasion over an irregular bony prominence.

Alongside this process of inflammation and deformity, other common associated problems for the hands and wrists are pain, weakness and restricted mobility resulting in loss of function and social participation.46 RA patients report hand function to be important in their daily lives,5 with at least 70% of patients reporting hand and wrist dysfunction.7

Pharmacological management of rheumatoid arthritis

Although there are increasingly effective drug treatments,8,9 the condition has no known cure. Thus, the goals of management are to prevent or control joint damage, loss of function and decrease pain.10 In order to achieve these goals, combinations of pharmacological, non-pharmacological and surgical treatments are used.

The chief categories of drugs used are analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying anti-rheumatic drugs (DMARDs) (non-biological and biological) and corticosteroids. NSAIDs offer a purely symptomatic treatment, commonly used when the disease flares up. There are a multitude of DMARDs licensed for use and it is now agreed that these should be used early on in the disease process for improved control.11 They are commonly used in combinations to achieve greater benefit but with no extra harm. Corticosteroids offer a fast-acting solution and are frequently used between changes in DMARD regimes. They can be used in oral, intravenous (IV) and intra-articular forms, depending on how widespread the scope of the problem. The side effects limit the long-term use of these drugs. Biological DMARDs, or biologics, are a relatively recent development in the management of RA. Owing to their greater financial cost, their use is restricted by National Institute for Health and Care Excellence (NICE) guidelines to patients whose disease is not controlled by conventional DMARDs.12 The main classes of biologics in common use at present are tumour necrosis factor (TNF) inhibitors or ‘anti-TNF’ (including infliximab, etanercept, adalimumab and certolizumab pegol) and rituximab, which works by depleting B lymphocytes. Newer biologics such as abatacept and tocilizumab are used where anti-TNF and rituximab do not work or cause adverse effects.

Non-pharmacological management of rheumatoid arthritis

Current UK clinical guidelines for the management of RA recommend the use of physiotherapy and occupational therapy as adjuncts to drug treatment.13,14 The three most common components of physiotherapy/occupational therapy for RA hands are exercise therapy, joint protection (JP) advice and provision of functional splinting and assistive devices,15 although we are not aware of any research describing current clinical practice in the NHS.

The use of exercise treatment for RA primarily aims to increase strength, stability and range of motion by tackling rheumatoid cachexia (loss of body cell mass and muscle architecture), disuse atrophy and joint/soft tissue restriction.16 Additional benefits may include reducing pain and increasing sensory–motor function.17 A systematic review18 of six randomised controlled trials (RCTs) of the effectiveness of dynamic general exercise programmes in RA concluded that dynamic exercise was effective in improving muscular endurance and strength, without having detrimental effects on disease activity or pain. The number of RCTs that have specifically investigated the effects of exercise on RA hands and wrists is limited to five small studies with short-term follow-up limited to a few months (n = 44, 50, 52, 44 and 67 individuals).1923 Each of these studies demonstrated small improvements in hand impairment and/or function with no increase in joint swelling, pain or disease activity.

Adherence to any exercise programme is crucial, as it is suggested that there is a dose–response relationship in both healthy and RA populations for strength and pain.24 Adherence with short-term supervised exercise programmes is generally high.25 However longer-term and home-based exercise programmes do not have the same response,26 although data are sparse. There is some evidence to show that a programme incorporating a behaviour-change framework based on the Health Belief Model27 is effective in maintaining long-term adherence in RA patients.28

Joint protection advice includes pain management advice, planning and pacing activities, regular rest, altering patterns of joint movement and assistive device use in order to minimise pain and fatigue and make tasks easier. This advice may be provided in the form of information leaflets (e.g. Looking After Your Joints When You Have Arthritis29), one-to-one sessions, group interventions or a combination of these. Evidence suggests that, provided appropriate education methods are applied, JP improves function and reduces pain in the short and long term.28,30

Provision of splinting is widespread in UK clinical practice,31 with the objectives of reducing hand and wrist pain, improving hand function and reduction or prevention of deformity and soft tissue contractures, although evidence of efficacy is unclear.32 Types of splinting may be categorised into resting or functional depending on the exact requirements of the patient.

Costs of rheumatoid arthritis

The economic cost of RA is substantial for both the individual patient and society as a whole.33 Patients with poor and declining function from their diagnosis of RA experience much higher costs of care overall.34 A report by the National Rheumatoid Arthritis Society in 2010 found that the overall cost of RA to the UK economy was almost £8B per annum, with NHS expenditure totalling approximately £700M.35 To date, no studies evaluating exercise in hand and wrist RA have detailed costs involved or included a cost-effectiveness analysis.

Rationale for Strengthening And stretching for Rheumatoid Arthritis of the Hand trial

Wrist and hand dysfunction as a result of pain, loss of movement and weakness is a common problem in RA. To address this, exercises are currently recommended as part of clinical management of people living with RA with an increasing shift towards more active treatments at an earlier stage. These recommendations are not supported by high-quality evidence.

With previous small-scale studies showing some promise over the short term, there is a clear need for long-term evaluation of an optimised hand exercise programme in a large group of people living with RA. As part of this evaluation, it is important that strategies to maximise programme adherence are incorporated and evaluated. A mixed-methods approach provides rich data that should facilitate understanding of why such a programme does or does not work.

In the Strengthening And stretching for Rheumatoid Arthritis of the Hand (SARAH) trial we evaluate a hand exercise programme that will be acceptable to NHS physiotherapists and occupational therapists based on current available evidence. Such a programme is over and above what is currently provided in the UK NHS. A parallel economic evaluation will enable conclusions to be made about cost-effectiveness.

Research objectives

  1. To estimate the clinical effectiveness of adding an optimised exercise programme for hands and upper limbs in addition to usual care in the reduction of hand dysfunction and pain for patients with RA.
  2. To estimate the cost-effectiveness of adding this programme to usual care.
  3. To describe, qualitatively, the experience of participants in the trial with a particular emphasis on acceptability of the intervention, exercise behaviours and reasons for adherence/non-adherence.

The null hypotheses of the study were that there would be no difference in either the clinical and cost outcomes between the two treatment arms.

Copyright © Queen’s Printer and Controller of HMSO 2015. This work was produced by Williams et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK279708

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