Open Access Study protocol

Exercise programme with telephone follow-up for people with hand osteoarthritis – protocol for a randomised controlled trial

Nina Østerås1*, Kåre Birger Hagen12, Margreth Grotle13, Anne-Lene Sand-Svartrud1, Petter Mowinckel1, Eline Aas4 and Ingvild Kjeken12

Author Affiliations

1 National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, PO Box 23 Vindern, N-0319 Oslo, Norway

2 Department of Health Sciences, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway

3 FORMI (Communication Unit for Musculoskeletal Disorders), Division for Surgery and Neurology, Oslo University Hospital, Ullevål, Olso, Norway

4 Department of Health Management and Health Economics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway

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BMC Musculoskeletal Disorders 2014, 15:82  doi:10.1186/1471-2474-15-82

Published: 14 March 2014

Abstract

Background

Hand osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases in an adult population and may have a large influence on an individual’s functioning, health-related quality of life and participation in society. Several studies have demonstrated that exercises may reduce pain and improve functioning in people with knee OA, with a similar effect suggested for hip OA. For hand OA, available research is very limited and shows conflicting results, and high-quality randomised controlled trials are warranted.

This paper outlines the protocol for a randomised controlled trial that aims to determine the effect of an exercise intervention on self-reported hand activity performance in people with hand OA.

Methods

Participants with physician-confirmed hand OA according to the ACR clinical criteria are being recruited from two Norwegian OA cohorts: the population-based “Musculoskeletal pain in Ullensaker Study” (MUST) OA cohort, and the hospital-based Oslo Hand OA cohort. Participants are randomised into an intervention- or control group. The control group receives “usual care”, whereas the intervention group receives a 12-week exercise intervention. The intervention group attends four group sessions and is instructed to perform the exercise program three times a week at home. Adherence will be captured using self-report. During the eight weeks with no group sessions, the intervention group receives a weekly telephone call. The assessments and group sessions are being conducted locally in Ullensaker Municipality and at Diakonhjemmet Hospital, Oslo. Outcomes are collected at baseline, and at 3 and 6 months. The primary outcome measure is self-reported hand activity performance at 3 months post-randomisation, as measured by the Functional Index for Hand Osteoarthritis (FIHOA); and a patient-generated measure of disability, the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are self-reported OA symptoms (e.g. pain, stiffness and fatigue), the Patient Global Assessment of disease activity, measured hand function (e.g. grip strength, thumb web space and hand dexterity) and health-related quality of life. Cost-utility and cost-effectiveness analyses will be conducted.

Discussion

This study will contribute to the knowledge on both the effect and resource use of an exercise programme with telephone follow-up on self-reported hand activity performance among people with hand OA.

Trial registration

The trial is registered at ClinicalTrials.gov with registration number: NCT01245842.

Keywords:
Osteoarthritis; Hand; Exercises; Randomised controlled trial; Study protocol