Shi's Yi-Qi Bu-Shen Tong-Luo decoction combined with manipulation in the management of wrist stiffness after distal radius fracture: Study protocol clinical trial (SPIRIT Compliant).

Introduction: Wrist stiffness is a common sequela of distal radial fractures. Manipulation is generally used and effective, but problems exist, such as intense pain, swelling during the process of manipulation and long treatment period. Therefore, a combinative therapeutic strategy is necessary to benefit rehabilitation after distal radius fracture. Shi's Yi-Qi Bu-Shen Tong-Luo decoction (BTD) combined with wrist manipulation has been used in the Shanghai Ninth People's Hospital Huangpu Branch in last few decades. BTD has potential therapeutic effects on rehabilitation after distal radius fracture, which should be evaluated by rigorous clinical trial.

Methods/design: A randomized, double-blind, placebo-controlled clinical trial will be conducted to determine the efficiency of BTD in relief of wrist stiffness and pain and function rehabilitation. A total of 80 wrist stiffness patients with or without pain and edema will be enrolled, and treated with wrist manipulation plus BTD or placebo for 4 weeks. The primary outcome measure is the Cooney wrist score. The second outcome measures include pain numerical rating scale, patient rated wrist evaluation, 36-item short form health survey questionnaire, and side effects.

Discussion: Although BTD has shown effects on rehabilitation after distal radius fracture in the Shanghai Ninth People's Hospital Huangpu Branch for decades, the universality of this efficacy needs evaluated. The results of this trial will provide a convincing evidence.

Trial Registration: ChiCTR2000029260, January 19, 2020.