远程康复锻炼计划与自我护理数字手册对慢性非特异性颈痛患者的效果:一项评估者盲法、3 个月随访的随机对照试验方案。
Effect of a telerehabilitation exercise program versus a digital booklet with self-care for patients with chronic non-specific neck pain: a protocol of a randomized controlled trial assessor-blinded, 3 months follow-up.
机构信息
Master's Program in Human Movement Sciences, Federal University of Pará, Belém-Pará, 66050-160, Brazil.
School of Health Sciences, Faculty of Medicine and Health, Sydney Musculoskeletal HealthCharles Perkins CentreUniversity of Sydney, Sydney, NSW, 2009, Australia.
出版信息
Trials. 2023 Sep 28;24(1):616. doi: 10.1186/s13063-023-07651-z.
BACKGROUND
Neck pain is the fourth worldwide leading cause of disability and represents 22% of musculoskeletal disorders. Conservative intervention has been strongly recommended to treat chronic neck pain and Telerehabilitation is the alternative for the treatment of musculoskeletal conditions. There is a lack of high-quality research on the effects of telerehabilitation in patients with neck pain and functional disability. Therefore, this study aims to evaluate the effect of a telerehabilitation exercise program versus a digital booklet only with self-care information in individuals with non-specific chronic neck pain.
METHODS
This is a prospectively registered, assessor-blinded, two-arm randomized controlled trial comparing a telerehabilitation exercise program versus a digital booklet with self-care information. Seventy patients will be recruited with non-specific chronic neck pain. Follow-ups will be conducted post-treatment, 6 weeks, and 3 months after randomization. The primary outcome will be disability at post-treatment (6 weeks) measured using neck pain disability. Secondary outcomes will be pain intensity levels, global perceived effect, self-efficacy, quality of life, kinesiophobia, and adherence to treatment. In our hypothesis, patients allocated to the intervention group experience outcomes that are similar to those of those assigned to the self-care digital booklet. Our hypothesis can then be approved or disapproved based on the results of the study.
DISCUSSION
This randomized clinical trial will provide reliable information on the use of telerehabilitation to treat patients with chronic non-specific neck pain.
TRIAL REGISTRATION
The study was prospectively registered at the Brazilian Registry of Clinical Trials (number: RBR-10h7khvk). Registered on 16 September 2022.
背景
颈部疼痛是全球第四大致残原因,占肌肉骨骼疾病的 22%。强烈建议采用保守干预措施来治疗慢性颈部疼痛,远程康复是治疗肌肉骨骼疾病的替代方法。对于颈部疼痛和功能障碍患者的远程康复效果,缺乏高质量的研究。因此,本研究旨在评估远程康复运动计划与仅提供自我护理信息的数字手册在非特异性慢性颈部疼痛患者中的效果。
方法
这是一项前瞻性注册、评估者盲法、双臂随机对照试验,比较远程康复运动计划与仅提供自我护理信息的数字手册。将招募 70 名患有非特异性慢性颈部疼痛的患者。随访将在治疗后、6 周和随机分组后 3 个月进行。主要结局指标是治疗后(6 周)的残疾程度,使用颈部疼痛残疾量表进行评估。次要结局指标包括疼痛强度水平、总体感觉效果、自我效能感、生活质量、运动恐惧和治疗依从性。在我们的假设中,分配到干预组的患者的结局与分配到自我护理数字手册组的患者相似。然后可以根据研究结果批准或不批准我们的假设。
讨论
这项随机临床试验将为使用远程康复治疗慢性非特异性颈部疼痛患者提供可靠的信息。
试验注册
该研究前瞻性地在巴西临床试验注册处(注册号:RBR-10h7khvk)进行注册。注册于 2022 年 9 月 16 日。