ITMCTR2000002931尚未招募2 期
Shi's Yi-Qi Bu-Shen Tong-Luo decoction combined with manipulation in the management of wrist stiffness after distal radius fracture: a single-center, double-blinded randomized controlled trial
Huangpu Branch, Shanghai Ninth People's Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 48 至 78（—）
- 性别
- All
入选标准
- •(1) patients with clear diagnosis of unilateral distal radius fracture and receiving conservative treatment such as plaster external fixation, small splint fixation and external fixation stent;
- •(2) patients aged 48 to 78 years old;
- •(3) clinical healing of the fracture, that is, X-ray 6 weeks after the fracture showed blurred fracture line and good callus growth, and external fixation such as plaster and support was removed;
- •(4) after 6 weeks of fracture, wrist dysfunction, stiffness, local swelling and pain were observed, and the range of motion of the joint was significantly lower than that of the healthy side;
- •(5) oral Chinese medicine and manipulation therapy are acceptable;
- •(6) Sign informed consent.
排除标准
- •(1) patients with allergic constitution or allergic to the test drugs or patients with serious adverse reactions to the test drugs;
- •(2) the fracture site has poor stability and is prone to redisplacement during rehabilitation;
- •(3) nerve injury in the affected limb or severe osteoporosis;
- •(4) cancer patients;
- •(5) mental disorders such as mania and depression;
- •(6) those with a history of infectious diseases, such as tuberculosis, hepatitis b, HIV and other infectious diseases;
- •(7) medical diseases with poor control, such as diabetes, hyperlipidemia, respiratory tract infection, etc.;
- •(8) having a history of abuse of opioid analgesics, sedatives and hypnotics and alcohol;
- •(9) severe liver or kidney disease or severe damage to liver and kidney function (ALT or AST is more than 1.5 times higher than the normal upper limit, and blood creatinine is more than 1.5 times higher than the normal upper limit);
- •(10) poor compliance, inability to cooperate with techniques and to meet the requirements of follow-up;
- •(11) patients who participated in clinical trials of other drugs within the last 3 months.
研究者
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