Effectiveness of multimodal exercises integrated with cognitive-behavioral therapy in working patients with chronic neck pain: protocol of a randomized controlled trial with 1-year follow-up

Background: The etiology of neck pain is multifactorial and includes personal and work-related factors such as age, sex, wrong postures, and repeated strains. Studies based on bio-psychosocial model also link chronic neck pain to psychological factors. Over time, the use of multidisciplinary interventions for chronic neck pain has grown in order to improve disability, pain, and adaptive cognitions and behaviors towards patients' problems. The objective is to evaluate the effectiveness of an individual-based multidisciplinary rehabilitation program that integrates cognitive-behavioral therapy focused on kinesiophobia with specific exercises in the treatment of patients with chronic neck pain, employed in different working activities. Methods: A randomized, parallel-group superiority-controlled trial will be conducted with 1-year follow-up. One hundred seventy patients engaged in several working activities (blue collar and white collar workers) will be randomly allocated to either the experimental (receiving a multidisciplinary rehabilitation program combining multimodal exercises with psychologist-lead cognitive-behavioral therapy sessions) or the control group (receiving general care physiotherapy). Both groups will follow individual-based programs once a week for 10 weeks. The main outcome measures will be the Neck Disability Index, the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale, the Short-Form Health Survey, and the Work Ability Index. Participants will be evaluated before, after training, and after 12 months. Discussion: Findings may provide empirical evidence on the effectiveness of an individual-based multidisciplinary rehabilitation program on inducing clinically significant and long-term improvements in the disability, pain, psychological factors, and quality of life of workers with chronic neck pain and that these would be maintained in the long term. Hence, this trial might contribute towards refining guidelines for good clinical practice and might be used as a basis for health authorities' recommendations. Trial registration: ClinicalTrials.gov NCT04768790 . Registered on 24 February 2021.