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Shishi Yiqi Bushen Tongluo decoction combined with manipulation in the management of wrist stiffness after distal radius fracture

Phase 1
Conditions
Distal Radius Fracture
Registration Number
ITMCTR2000002916
Lead Sponsor
Huangpu Branch, Shanghai Ninth People's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(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) the patients were between 48 and 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.

Exclusion Criteria

(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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cooney Wrist Score;
Secondary Outcome Measures
NameTimeMethod
umerical rating scale;adverse events;the MOS item short from health survey, SF-36;Patient-Rated Wrist Evaluation Score;
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