Efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' on return to work for sick-listed citizens: design of a randomised controlled trial.
BACKGROUND
Pain affects quality of life and can result in absence from work. Treatment and/or prevention strategies for musculoskeletal pain-related long-term sick leave are currently undertaken in several health sectors. Moreover, there are few evidence-based guidelines for such treatment and prevention. The aim of this study is to evaluate the efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' for sick-listed citizens with pain in the back and/or the upper body.


METHODS
This protocol describes the design of a parallel randomised controlled trial on the efficacy of 'Tailored Physical Activity' or a 'Chronic Pain Self-management Program' versus a reference group for sick-listed citizens with complaints of pain in the back or upper body. Participants will have been absent from work due to sick-listing for 3 to 9 weeks at the time of recruitment. All interventions will be performed at the 'Health Care Center' in the Sonderborg Municipality, and a minimum of 138 participants will be randomised into one of the three groups.All participants will receive 'Health Guidance', a (1.5-hour) individualised dialogue focusing on improving ways of living, based on assessments of risk behavior, motivation for change, level of self-care and personal resources. In addition, the experimental groups will receive either 'Tailored Physical Activity' (three 50-minute sessions/week over 10 weeks) or 'Chronic Pain Self-Management Program' (2.5-hours per week over 6 weeks). The reference group will receive only 'Health Guidance'.The primary outcome is the participants' sick-listed status at 3 and 12 months after baseline. The co-primary outcome is the time it takes to return to work. In addition, secondary outcomes include anthropometric measurements, functional capacity and self-reported number of sick days, musculoskeletal symptoms, general health, work ability, physical capacity, kinesiophobia, physical functional status, interpersonal problems and mental disorders.


CONCLUSIONS
There are few evidence-based interventions for rehabilitation programmes assisting people with musculoskeletal pain-related work absence. This study will compare outcomes of interventions on return to work in order to increase the knowledge of evidence-based rehabilitation of sick-listed citizens to prevent long-term sick-leave and facilitate return to work.


BACKGROUND
The trial is registered in the ClinicalTrials.gov, number NCT01356784.
Institute of Sports Science and Clinical Biomechanics, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. lonygaard@health.sdu.dk
Lotte Nygaard
LN
Andersen
Birgit
B
Juul-Kristensen
Kirsten Kaya
KK
Roessler
Lene Gram
LG
Herborg
Thomas Lund
TL
Sørensen
Karen
K
Søgaard
D001416:Back Pain / Q000534:rehabilitation*; D059350:Chronic Pain / Q000534:rehabilitation*; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D059352:Musculoskeletal Pain / Q000534:rehabilitation*; D015397:Program Evaluation; D012107:Research Design; D062707:Return to Work / Q000706:statistics & numerical data*; D012648:Self Care / Q000379:methods*; D018582:Sick Leave / Q000706:statistics & numerical data; D013997:Time Factors; D016896:Treatment Outcome