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）：这项带有安慰剂对照的双盲随机试验研究了外部气功疗法（EQT）对于缓解膝盖骨关节炎（OA）患者疼痛和改善症状的临床效果。 关节炎是美国残疾的主要原因。 目前针对 OA 的药物疗法在控制症状方面在不同程度上有效，但存在显着的缺点，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，成本较低且无副作用。 具体目的包括：（1）探讨外气功疗法治疗骨关节炎的有效性； （2）考察气功疗法减少关节炎患者焦虑、抑郁等负面情绪的短期和长期能力； (3) 测试暗示性作为疼痛减轻的预测因素，以及它是否改变气功治疗的效果，从而使得治疗在暗示性较低的受试者中可能效果较差。 这些目标将通过对 70 名膝关节骨关节炎患者进行对照临床试验来实现，并将他们随机分配到气功治疗组或假治疗组。 气功治疗是由治疗师对受影响的关节部位“发气”，每次5-10分钟，两周内总共5次。计划治疗后 3 个月进行随访，以评估长期疗效。 疗效衡量标准将主要采用 WOMAC OA 指数，其中包括疼痛、僵硬和身体困难三个分量表，以及麦吉尔疼痛问卷 (SF)、斯皮尔伯格焦虑量表、贝克曼抑郁量表、洛里格自我效能量表和肿胀/压痛关节计数。 此外，将监测基线和整个干预期间平均每日 NSAID 和镇痛药剂量以及其他 CAM 治疗的历史，以评估治疗后可能的变化。 将通过学生 t 检验评估治疗组之间改善程度的差异。混合效应模型和重复测量的多元方差分析将用于检查疼痛、僵硬、身体困难和焦虑程度的变化，并控制人口统计、疼痛史、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权威研究，而是原理证明。 这项试点试验应该为更系统地探索气功练习（自我练习）和 EQT 在减少或消除慢性关节炎疼痛方面的益处奠定基础。