Study protocol

Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of an RCT [ISRCTN71777817]

Camiel De Bruijn^1,2 , Rob de Bie^1,3 , Jacques Geraets^1,3 , Marielle Goossens^1,4 , Albère Köke^5,7 , Wim van den Heuvel¹ , Geert van der Heijden⁶ and Geert-Jan Dinant²

¹  Institute for Rehabilitation Research, Hoensbroek, The Netherlands

²  Department of General Practice and Care and Public Health Research Institute, Maastricht University, The Netherlands

³  Department of Epidemiology, Maastricht University, The Netherlands

⁴  Department of Medical, Clinical and Experimental Psychology, Maastricht University, The Netherlands

⁵  Hoensbroek Rehabilitation Centre, Hoensbroek, The Netherlands

⁶  Julius Center for Health Sciences and Primary Care, University Medical Centre, Utrecht, The Netherlands

⁷  Pain Management and Research Centre, University Hospital Maastricht, The Netherlands

author email corresponding author email

BMC Family Practice 2005, 6:7doi:10.1186/1471-2296-6-7

Published:	16 February 2005

Abstract

Background

About half of all newly presented episodes of shoulder complaints (SC) in general practice are reported to last for at least six months. Early interventions aimed at the psychological and social determinants of SC are not common in general practice, although such interventions might prevent the development of chronic SC.

The Education and Activation Programme (EAP) consists of an educational part and a time-contingent activation part. The aim of the EAP is to provide patients with the proper cognitions by means of education, and to stimulate adequate behaviour through advice on activities of daily living.

Design

The article describes the design of a randomised clinical trial (RCT) to evaluate the effectiveness and cost-effectiveness of an EAP in addition to usual care, compared to usual care only, in the prevention of chronic SC after six months. It also describes the analysis of the cost and effect balance. Patients suffering from SC for less than three months are recruited in general practice and through open recruitment. A trained general practitioner or a trained therapist administers the EAP.

Primary outcome measures are patient-perceived recovery, measured by self-assessment on a seven-point scale, and functional limitations in activities of daily living. Questionnaires are used to study baseline measures, prognostic measures, process measures and outcome measures.

Discussion

The inclusion of patients in the study lasted until December 31^st 2003. Data collection is to end in June 2004.