title: Self management, joint protection and exercises in hand osteoarthritis: a randomised controlled trial with cost effectiveness analyses.
abstract: BACKGROUND
  There is limited evidence for the clinical and cost effectiveness of occupational therapy (OT) approaches in the management of hand osteoarthritis (OA). Joint protection and hand exercises have been proposed by European guidelines, however the clinical and cost effectiveness of each intervention is unknown.This multicentre two-by-two factorial randomised controlled trial aims to address the following questions:• Is joint protection delivered by an OT more effective in reducing hand pain and disability than no joint protection in people with hand OA in primary care?• Are hand exercises delivered by an OT more effective in reducing hand pain and disability than no hand exercises in people with hand OA in primary care?• Which of the four management approaches explored within the study (leaflet and advice, joint protection, hand exercise, or joint protection and hand exercise combined) provides the most cost-effective use of health care resources
  
  
  METHODS
  Participants aged 50 years and over registered at three general practices in North Staffordshire and Cheshire will be mailed a health survey questionnaire (estimated mailing sample n = 9,500). Those fulfilling the eligibility criteria on the health survey questionnaire will be invited to attend a clinical assessment to assess for the presence of hand or thumb base OA using the ACR criteria. Eligible participants will be randomised to one of four groups: leaflet and advice; joint protection (looking after your joints); hand exercises; or joint protection and hand exercises combined (estimated n = 252). The primary outcome measure will be the OARSI/OMERACT responder criteria combining hand pain and disability (measured using the AUSCAN) and global improvement, 6 months post-randomisation. Secondary outcomes will also be collected for example pain, functional limitation and quality of life. Outcomes will be collected at baseline and 3, 6 and 12 months post-randomisation. The main analysis will be on an intention to treat basis and will assess the clinical and cost effectiveness of joint protection and hand exercises for managing hand OA.
  
  
  CONCLUSIONS
  The findings will improve the cost-effective evidence based management of hand OA.
  
  
  BACKGROUND
  identifier: ISRCTN33870549.
authors: Arthritis Research UK Primary Care Centre, Keele University, Keele, Staffordshire, ST5 5BG, UK. k.s.dziedzic@cphc.keele.ac.uk
authors: Krysia S
authors: KS
authors: Dziedzic
authors: Susan
authors: S
authors: Hill
authors: Elaine
authors: E
authors: Nicholls
authors: Alison
authors: A
authors: Hammond
authors: Helen
authors: H
authors: Myers
authors: Tracy
authors: T
authors: Whitehurst
authors: Jo
authors: J
authors: Bailey
authors: Charlotte
authors: C
authors: Clements
authors: David G T
authors: DG
authors: Whitehurst
authors: Sue
authors: S
authors: Jowett
authors: June
authors: J
authors: Handy
authors: Rhian W
authors: RW
authors: Hughes
authors: Elaine
authors: E
authors: Thomas
authors: Elaine M
authors: EM
authors: Hay
mesh_terms: D000203:Activities of Daily Living; D003362:Cost-Benefit Analysis / Q000191:economics / Q000379:methods*; D005081:Exercise Therapy / Q000191:economics* / Q000379:methods; D005260:Female; D050823:Hand Joints / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009788:Occupational Therapy / Q000191:economics / Q000379:methods; D010003:Osteoarthritis / Q000191:economics* / Q000503:physiopathology / Q000534:rehabilitation*; D010865:Pilot Projects; D017410:Practice Guidelines as Topic; D006113:United Kingdom