Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
Neurorehabilitation Unit, Department of Neuroscience and Rehabilitation, G. Brotzu Hospital, Cagliari, Italy.
Trials. 2022 May 21;23(1):425. doi: 10.1186/s13063-022-06340-7.
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.
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.
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.
ClinicalTrials.gov NCT04768790 . Registered on 24 February 2021.
颈部疼痛的病因是多因素的,包括个人和与工作相关的因素,如年龄、性别、姿势不当和反复劳损。基于生物-心理-社会模式的研究也将慢性颈部疼痛与心理因素联系起来。随着时间的推移,为了改善残疾、疼痛和对患者问题的适应性认知和行为,多学科干预慢性颈部疼痛的使用不断增加。目的是评估一种个体化的多学科康复方案的有效性,该方案将针对运动恐惧症的认知行为疗法与特定运动相结合,用于治疗从事不同工作活动的慢性颈部疼痛患者。
将进行一项为期 1 年随访的随机、平行组优效对照试验。将 170 名从事多种工作活动(蓝领和白领工人)的患者随机分配到实验组(接受结合多模式运动和心理学家主导的认知行为疗法的多学科康复方案)或对照组(接受常规物理治疗)。两组均每周接受一次个体化方案治疗,共 10 周。主要结局指标为颈部残疾指数、坦帕运动恐惧症量表、疼痛灾难化量表、疼痛数字评分量表、简明健康调查量表和工作能力指数。参与者将在训练前、训练后和 12 个月后进行评估。
研究结果可能为基于个体的多学科康复方案在诱导慢性颈痛患者的残疾、疼痛、心理因素和生活质量的临床显著和长期改善方面的有效性提供实证证据,并且这些改善将在长期内得到维持。因此,这项试验可能有助于完善良好临床实践指南,并可能成为卫生当局建议的基础。
ClinicalTrials.gov NCT04768790。于 2021 年 2 月 24 日注册。