Evaluation of the efficacy of a short-course, personalized self-management and intensive spa therapy intervention as active prevention of musculoskeletal disorders of the upper extremities (Muska): a research protocol for a randomized controlled trial

评估短期个性化自我管理和强化水疗干预措施对预防上肢肌肉骨骼疾病(Muska)的有效性:一项随机对照试验的研究方案

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Abstract

BACKGROUND: Musculoskeletal disorders (MSDs) constitute a major occupational health problem in the working population, substantially impacting the quality of life of employees. They also cause considerable economic cost to the healthcare system, with, notably, the reimbursement of treatments and compensation for lost income. MSDs manifest as localized pain or functional difficulty in one or more anatomical areas, such as the cervical spine, shoulder, elbow, hand, and wrist. Although prevalence varies depending on the region considered and the method of assessment, a prevalence of 30% is found in different epidemiological studies. The disease needs to be prevented, not only for medical and economic reasons, but also for legal reasons, owing to the requirement of assessing occupational risks. The strategy envisaged may thus revolve around active, multimodal prevention that has employees fully involved at the heart of their care. Although physical exercise is widely recommended, few studies with a good level of evidence have enabled us to base a complete, well-constructed intervention on exercise that can be offered as secondary prevention in these disorders. METHODS: A prospective, multicenter, comparative (intervention arm vs. control arm), randomized (immediate vs. later treatment) study using Zelen's design. This study falls under active prevention of MSDs of the upper extremities (UE-MSDs). Participants are workers aged between 18 and 65 years with latent or symptomatic MSDS, with any type of job or workstation, with or without an history of sick leave. The primary aim is to show the superiority at 3 months of a combination of spa therapy, exercise, and self-management workshops for 6 days over usual care in the management of MSDs in terms of employee functional capacity in personal and professional daily life. Secondary aims are to assess the benefit of the intervention in terms of pain, quality of life, and accumulated duration of sick leave. DISCUSSION: This randomized controlled trial is the first that will aim to evaluate multidisciplinary management of UE-MSDs using nonpharmacological treatment combining exercise, self-management, and spa therapy. The originality of this intervention lies, in its short, intensive format, which is compatible with remaining in work; and in its multidisciplinary approach. This trial has the potential to demonstrate, with a good level of evidence, the benefits of a short course of spa therapy combined with a personalized self-management program on the functional capacity, pain, and quality of life of employees in their daily life. TRIAL REGISTRATION: Clinical trial.gov NCT02702466 retrospectively registered. PROTOCOL: Version 4 of 9/10/2015.

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