Lirio Romero Cristina, Torres Lacomba María, Castilla Montoro Yurema, Prieto Merino David, Pacheco da Costa Soraya, Velasco Marchante María Jesús, Bodes Pardo Gema
Physiotherapist, State Center of Attention to Brain Injury, Madrid, Spain.
Professor, University of Alcalá, Madrid, Spain.
J Chiropr Med. 2015 Dec;14(4):249-58. doi: 10.1016/j.jcm.2015.03.001. Epub 2015 Nov 24.
The purpose of this study was to evaluate the feasibility of the methods proposed to conduct a full randomized clinical trial to assess the effectiveness of mobilization with movement on shoulder functionality in older adults with shoulder dysfunction.
A pilot, randomized, single-blinded clinical trial was carried out with 44 older adults (83.9±8.2 years) with shoulder dysfunction in 3 nursing homes in Toledo, Spain. Participants were recruited through information sessions and were randomly allocated into 2 groups. The control group (n = 22) intervention consisted of a physical therapy standard protocol proposed by the Spanish Rheumatology Society. Techniques based on Mulligan's concepts of mobilization with movement were added to the standard protocol for the experimental group (n = 22) intervention. Interventions took place 3 times a week for 2 consecutive weeks and were performed by 2 experienced therapists. Main outcomes were recruitment rates, participation and adherence to interventions, assessment procedures, and the implementation of mobilization with movement. Clinical outcomes were shoulder functionality, active glenohumeral range of motion, and pain intensity. Data were collected at baseline, after each group intervention, and at 1 and 3 months after finishing interventions.
All the participants accepted to be randomized. Participation rates were 97.7% for the experimental group and 95.5% for the control group. The analysis of variance did not show any statistically significant difference between treatment groups for any of the variables (all P values for the group effect were greater than .36) or a change of the difference between groups over time (all P values for the time-treatment interactions were greater than .3).
The research methods tested in this pilot study offer a suitable foundation to conduct a full clinical trial.
本研究旨在评估所提出的方法用于开展一项全面随机临床试验的可行性,该试验旨在评估活动度松动术对患有肩部功能障碍的老年人肩部功能的有效性。
在西班牙托莱多的3家养老院对44名患有肩部功能障碍的老年人(83.9±8.2岁)进行了一项试点随机单盲临床试验。通过信息发布会招募参与者,并将其随机分为2组。对照组(n = 22)的干预措施包括西班牙风湿病学会提出的物理治疗标准方案。实验组(n = 22)的干预措施在标准方案基础上增加了基于穆利根活动度松动术概念的技术。干预每周进行3次,连续进行2周,由2名经验丰富的治疗师实施。主要结果包括招募率、对干预措施的参与度和依从性、评估程序以及活动度松动术的实施情况。临床结果包括肩部功能、主动肩关节活动范围和疼痛强度。在基线、每组干预后以及干预结束后1个月和3个月收集数据。
所有参与者均接受随机分组。实验组的参与率为97.7%,对照组为95.5%。方差分析显示,治疗组之间在任何变量上均无统计学显著差异(所有组效应的P值均大于0.36),且组间差异随时间无变化(所有时间 - 治疗交互作用的P值均大于0.3)。
本试点研究中测试的研究方法为开展全面临床试验提供了合适的基础。