Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial.
BACKGROUND
Non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA). The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions.


METHODS
In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse). The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks.


CONCLUSIONS
This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA.


BACKGROUND
Dutch Trial Register NTR2137.
Hoogeboom
Thomas J
TJ
Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands. t.hoogeboom@maartenskliniek.nl.
Stukstette
Mirelle J P M
MJ
de Bie
Rob A
RA
Cornelissen
Jessica
J
den Broeder
Alfons A
AA
van den Ende
Cornelia H M
CH
D000203:Activities of Daily Living; D000328:Adult; D002985:Clinical Protocols; D003131:Combined Modality Therapy / Q000191:economics / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D009726:Nurses / Q000191:economics; D010003:Osteoarthritis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010348:Patient Care Team; D017060:Patient Satisfaction; D026741:Physical Therapy Modalities / Q000191:economics; D011788:Quality of Life; D012648:Self Care / Q000191:economics / Q000379:methods; D012647:Self-Assessment; D011795:Surveys and Questionnaires