Qigong Therapy for Osteoarthritis at Knees

气功治疗膝骨关节炎

• 批准号: 6947920
• 负责人: KEVIN W CHEN
• 金额: $ 19.03万
• 依托单位: UNIV OF MED/DENT NJ-R W JOHNSON MED SCH
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2006-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6947920
• 关键词: alternative medicine; anxiety; arthritis therapy; behavior prediction; behavioral /social science research tag; chronic pain; clinical research; clinical trials; depression; functional ability; human subject; human therapy evaluation; knee; osteoarthritis; patient oriented research; questionnaires; suggestion

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.

描述（由申请人提供）：本双盲随机试验采用安慰剂对照，研究外气功疗法（EQT）对膝关节骨关节炎（OA）患者疼痛缓解和症状改善的临床疗效。关节炎是美国致残的主要原因。目前OA的药物治疗方法在控制症状方面都有不同程度的效果，但成本、毒性和其他潜在的有害影响等缺点明显。气功疗法可能是一种成本低、无副作用的有效的非药物治疗关节炎的方法。具体目的包括：(1)探讨外气功疗法治疗骨关节炎的疗效；(2)考察气功疗法降低关节炎患者焦虑、抑郁等负性情绪的短期和长期能力；(3)测试易受暗示作为减轻疼痛的预测因素，以及它是否会改变气功治疗的效果，从而使气功治疗在易受暗示的受试者中可能效果较差。这些目标将通过对70例膝关节OA患者的对照临床试验来实现，并将他们随机分为气功组和假治疗组。气功治疗包括由治疗师对患处关节部位“放气”，每次5-10分钟，在两周内共进行5次。计划治疗后3个月随访以评估长期疗效。疗效的衡量将主要采用WOMAC OA指数，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，将监测非甾体抗炎药和镇痛药的平均每日剂量和其他辅助替代疗法的历史，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检验进行评估。混合效应模型和重复测量的方差分析将用于检查疼痛程度、僵硬、身体困难和焦虑的变化，同时控制人口统计学、疼痛史、药物剂量和其他潜在的混杂因素。提议的EQT试验不是对治疗的决定性研究，而是对原理的证明。这项试点试验应该为更系统地探索气功锻炼（自我练习）和殷拓在减少或消除慢性关节炎疼痛方面的益处提供基础。