Medina-Porqueres Ivan, Cantero-Tellez Raquel
Department of Physical Therapy, Physical Therapy Section, Faculty of Health Sciences, University of Malaga, Malaga, Spain.
Physiother Res Int. 2018 Apr;23(2):e1706. doi: 10.1002/pri.1706. Epub 2018 Mar 9.
Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. The aim of the proposed study is to assess the effect of Class IV laser therapy (LT) on pain and pinch strength in patients with thumb carpometacarpal (TCMC) OA.
A randomized, controlled, single-centre, double-blind, clinical trial, with 1:1 allocation ratio, will be carried out involving patients presenting TCMC-OA Grades 1-2 (aged >18 years). Both assessor and statistician will remain blinded. Patients with TCMC-OA will be randomly assigned to the experimental group (will receive LT) and control group (will receive a placebo treatment). Outcome measures will be pain scores at the base of the thumb measured with visual analogue scale (0-10: 0, no pain and 10, worst pain) and changes in pinch strength, both collected at baseline, 4, and 12 weeks. Statistical analyses will be based on an intention-to-treat analysis using the last value forward method. A two-tailed independent Student's t test for the continuous variable of age and baseline scores will be used for comparison of baseline characteristics and outcome variables. Paired Student's t tests will be used to determine the level of significance of the differences between the pretreatment and posttreatment measurements of the individual groups. Repeated measures analysis of variance will be used to determine the differences in time as the within-subjects factor and group as the between-subjects factor.
To our knowledge, the results of this study will provide the first double-blinded evidence for Class IV LT in patients with TCMC-OA.
骨关节炎（OA）是一种慢性且常见的关节疾病，对生活质量有很大影响，并带来高昂的经济负担。尽管多种保守治疗方法已被证明对手部OA的治疗有效，但大多数个体干预措施的治疗效果有限。本研究的目的是评估IV类激光疗法（LT）对拇指腕掌关节（TCMC）OA患者疼痛和捏力的影响。
将进行一项随机、对照、单中心、双盲临床试验，分配比例为1:1，纳入TCMC - OA 1 - 2级（年龄>18岁）的患者。评估者和统计人员都将保持盲态。TCMC - OA患者将被随机分配到实验组（接受LT）和对照组（接受安慰剂治疗）。观察指标将包括用视觉模拟量表（0 - 10：0表示无疼痛，10表示最剧烈疼痛）测量的拇指根部疼痛评分，以及捏力的变化，均在基线、4周和12周时收集。统计分析将基于意向性分析，采用末次值结转法。对于年龄和基线评分的连续变量，将使用双尾独立样本t检验来比较基线特征和观察指标变量。配对样本t检验将用于确定各治疗组治疗前和治疗后测量值之间差异的显著性水平。重复测量方差分析将用于确定时间（作为组内因素）和组（作为组间因素）之间的差异。
据我们所知，本研究结果将为TCMC - OA患者接受IV类LT提供首个双盲证据。
