• Jinhai Xu, Xiaoning Zhou, Chen Xu, Chongqing Xu, Xing Ding, Kun Jin, Ming Yan, Junming Ma, Xuequn Wu, Jie Ye, Wen Mo, and Wen Yuan.
• Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.
• Medicine (Baltimore). 2020 Sep 4; 99 (36): e21994.

BackgroundCervical spondylotic myelopathy (CSM) is the most serious type of cervical spondylosis, which is often treated surgically in patients with progressive neurological symptoms following ineffective conservative treatment. However, some patients have residual symptoms such as neck pain, stiffness, and C5 nerve palsy after surgery. The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery.Methods/DesignA multicenter, randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the Qishe Pill. A total of 330 patients with CSM who receive surgical treatment will be randomly divided into 2 groups, treated for 12 weeks and with a 1-year follow-up. The primary outcome will be Japanese Orthopaedic Association score from the baseline to 4 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery. Secondary outcomes will include Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray). Additionally, adverse reactions will be observed and recorded as safety indicators.DiscussionAlthough the Qishe pill can effectively improve the discomfort of the neck and upper limbs in clinical applications, there is a lack of clinical research on postoperative patients. This study will investigate the efficacy and safety of the Qishe pill in treating postoperative symptoms of CSM.Trial RegistrationClinical Trials.gov ID: ChiCTR1900028173. Registered on 17 December 2019.

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