Qigong Therapy for Osteoarthritis at Knees

描述(申请人提供)：这项具有安慰剂对照的双盲随机试验调查了外气功疗法(EQT)对膝骨性关节炎(OA)患者缓解疼痛和改善症状的临床疗效。在美国，关节炎是导致残疾的主要原因。目前治疗骨性关节炎的药物治疗在控制症状方面有不同程度的有效，但存在明显的缺点，如成本、毒性和其他潜在的有害影响。气功疗法可能是治疗关节炎的一种有效的非药物治疗方法，且费用低，无副作用。具体目标包括：(1)研究外气功疗法治疗骨性关节炎的有效性；(2)检验气功疗法在降低关节炎患者焦虑或抑郁等负面情绪方面的短期和长期能力；(3)测试可提示性作为疼痛减轻的预测指标，以及它是否会改变气功疗法的效果，从而使易受暗示的受试者的治疗效果可能较差。这些目标将通过对70名膝关节骨性关节炎患者进行对照临床试验来实现，并将他们随机分为气功治疗组或假治疗组。气功疗法包括由治疗师向患侧关节部位放气，每次5-10分钟，在2周内共进行5次。计划在治疗后3个月进行随访，以评估远期疗效。疗效的衡量将主要通过WOMAC OA指数来衡量，该指数包括疼痛、僵硬和身体困难三个子量表，以及McGill疼痛问卷(SF)、Spielberger焦虑量表、Beckman抑郁量表、Lorig的自我效能量表和肿胀/压痛关节计数。此外，在基线和整个干预过程中，将监测每日平均非甾体抗炎药和镇痛剂剂量以及其他CAM疗法的历史，以评估治疗后可能发生的变化。治疗组之间改善程度的差异将用学生t检验来评估。混合效应模型和重复测量的Manova将被用来检查疼痛程度、僵硬、身体困难和焦虑的变化，并控制人口统计学、疼痛病史、药物剂量和其他潜在的混杂因素。拟议的EQT试验并不是对该疗法的最终研究，而是对原则的证明。这项先导试验应该为更系统地探索气功锻炼(自我练习)和EQT在减轻或消除慢性关节炎疼痛方面的益处提供基础。

DESCRIPTION (provided by applicant): This dual-blinded randomized trial with placebo control investigates the clinical effectiveness of external Qigong therapy (EQT) for pain relief and symptom improvement in patients with osteoarthritis (OA) at the knees. Arthritis is the leading cause of disability in America. Current pharmacological therapies for OA are effective to various degrees in controlling symptoms with significant drawbacks like cost, toxicity and other potential detrimental effects. Qigong therapy might be an effective non-pharmacological treatment for arthritis with less cost and no side effect. The specific aims include: (1) to investigate the effectiveness of external qigong therapy for treating osteoarthritis; (2) to examine the short-term and long-term ability of Qigong therapy to decrease negative mood such as anxiety or depression among arthritis patients; and (3) to test suggestibility as a predictor of pain reduction and whether it modifies the effect of Qigong treatment, such that the treatment might be less effective among less suggestible subjects. These aims will be achieved through a controlled clinical trial of 70 patients with OA at knees, and randomly assign them into either the qigong or the sham treated group. Qigong treatment consists of "qi emission" by the therapist toward the affected joint area for 5-10 minutes in each session, for a total of 5 sessions within 2 weeks. A follow-up 3 months after the treatment is planned to evaluate the long-term effectiveness. The measures of efficacy will be primarily by WOMAC OA index, which includes three subscales for pain, stiffness and physical difficulty, as wells as the McGill Pain Questionnaire (SF), Spielberger Anxiety Scale, Beckman Depression Inventory, Lorig's self-efficacy scale, and swollen/tender joint count. In addition, a history of average daily NSAID and analgesics dosages and other CAM therapies at the baseline and throughout the intervention will be monitored to assess possible changes after the treatment. Differences in the degree of improvement between the treatment groups will be assessed with Student t test. The mixed effect model and MANOVA with repeated measures will be used to examine changes in degree of pain, stiffness, physical difficulty and anxiety, with control for demographics, pain history, drug dosage and other potential confounders. The proposed trial of EQT is not a definitive study of the therapy but a proof of principle. This pilot trial should provide a foundation for a more systematic exploration of the benefits of qigong exercise (self-practice) and EQT in reducing or eliminating chronic arthritis pain.