Avellanet Merce, Boada-Pladellorens Anna, Perrot Jean-Claude, Loro Laura, Rodrigo Cansado Lidia, Monterde David, Romagosa Josep, Gea Elvira
Rehabilitation Department, Hospital Nostra Senyora de Meritxell, Escaldes- Engordany, Andorra.
Department of Health, Catalan Health Institute, Govern de Catalunya, Barcelona, Spain.
JMIR Res Protoc. 2020 Apr 16;9(4):e14807. doi: 10.2196/14807.
There is a high prevalence of work-related musculoskeletal disorders among health care professionals. Posture is an essential point to be addressed for health care professionals with musculoskeletal disorders. Cervical pain can result from several conditions. Treatment should include posture modification and home exercise.
This study aims to compare a new postural garment (Posture Plus Force; Medi, Bayreuth, Germany) with exercises for women with nonspecific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work-related musculoskeletal disorders.
This randomized crossover clinical trial has a 3-month treatment sequence and a 3-month washout period. Participants will include nurses and allied health professionals 21 to 55 years of age with cervical pain. Participants are allocated at random to two intervention groups: a postural garment (Posture Plus Force) to be worn for 2 to 4 hours per day for 90 days (P+ group) and five physiotherapy sessions (20 minutes each) to learn stretching and strengthening exercises with instructions to continue at home on a daily basis for 90 days (Ex group). The participants in each group will crossover interventions after a 3-month washout period. The primary outcomes are postural control and pain intensity. A static posturography will be performed with a scan (SpinalMouse; Idiag AG, Fehraltorf, Switzerland). The visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual participants. The secondary outcomes are cervical pain-related disability, catastrophizing, the global perceived effect of treatment, and the evaluation of garment comfort. Physical activity is assessed with the International Physical Activity Questionnaire. Assessment of primary and secondary outcomes is performed at T0 (pre-intervention), T1 (immediately after garment fitting for P+ group), T30, T60, and T90. The same measurements are recorded after the washout period and during the second intervention following the same sequence. All patients are provided with a logbook for compliance recording, over the counter drug use, pain evaluation, and sick leave. Statistical analysis is conducted following intention-to-treat principles and the treatment effects calculated using linear mixed models.
The study design has been approved by the Ethics Commission of Hospital N Sra de Meritxell, Andorra in March 2017. A total of 32 participants are already enrolled in the study. An extension of the study is planned in a Spanish university hospital to achieve a larger sample. Study results are expected to be published during 2020.
The Postural garment is expected to improve cervical pain by enhancing posture.
ClinicalTrials.gov NCT03560492; https://clinicaltrials.gov/ct2/show/NCT03560492.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14807.
医疗保健专业人员中与工作相关的肌肉骨骼疾病患病率很高。姿势是患有肌肉骨骼疾病的医疗保健专业人员需要解决的关键问题。颈部疼痛可能由多种情况引起。治疗应包括姿势调整和家庭锻炼。
本研究旨在比较一种新型姿势矫正服装（Posture Plus Force；德国拜罗伊特的Medi公司）与针对非特异性颈部疼痛女性的锻炼效果。由于姿势在与工作相关的肌肉骨骼疾病中的重要性，研究人员将重点关注护士和专职医疗人员。
这项随机交叉临床试验有一个为期3个月的治疗期和一个为期3个月的洗脱期。参与者将包括年龄在21至55岁之间、患有颈部疼痛的护士和专职医疗人员。参与者被随机分配到两个干预组：一种姿势矫正服装（Posture Plus Force），每天佩戴2至4小时，持续90天（P+组）；以及五次物理治疗课程（每次20分钟），学习拉伸和强化锻炼，并按指示在家中每天继续进行90天（锻炼组）。每组参与者在3个月的洗脱期后将交叉进行干预。主要结局指标是姿势控制和疼痛强度。将使用扫描设备（SpinalMouse；瑞士费尔拉托夫的Idiag AG公司）进行静态姿势描记。视觉模拟量表是一种心理测量工具，旨在记录个体参与者的颈部疼痛严重程度。次要结局指标是与颈部疼痛相关的残疾、灾难化思维、治疗的总体感知效果以及服装舒适度评估。使用国际体力活动问卷评估体力活动。在T0（干预前）、T1（P+组服装试穿后立即）、T30、T60和T90进行主要和次要结局指标的评估。在洗脱期后以及第二次干预期间，按照相同顺序记录相同的测量值。为所有患者提供一本日志，用于记录依从性、非处方药物使用、疼痛评估和病假情况。按照意向性分析原则进行统计分析，并使用线性混合模型计算治疗效果。
该研究设计于2017年3月获得安道尔N Sra de Meritxell医院伦理委员会的批准。共有32名参与者已登记参加该研究。计划在一家西班牙大学医院扩大该研究，以获得更大的样本量。预计研究结果将于2020年发表。
预计这种姿势矫正服装通过改善姿势来缓解颈部疼痛。
ClinicalTrials.gov NCT03560492；https://clinicaltrials.gov/ct2/show/NCT03560492。
国际注册报告识别码（IRRID）：DERR1-10.2196/14807。
