Efficacy and safety of Tong-luo Qu-tong plaster for cervical spondylotic radiculopathy: study protocol for a randomized, double-blind, parallel positive controlled, multicenter clinical trial

Abstract

Abstract Background: Cervical spondylotic radiculopathy (CSR) is one of the most common diseases in clinic. Clinical symptoms such as neck pain and upper limb numbness are mainly caused by cervical degenerative changes and compression of cervical nerve roots. The incidence of CSR is the highest among all types of cervical spondylosis, accounting for about 60%~70%, seriously affecting the quality of life and work, causing huge economic negative to patients. Traditional Chinese medicine (TCM) has been definited efficacy and unique advantages in the treatment of CSR. Tongluo Qutong plaster (TLQT) is the most commonly used external drug in China in the treatment of CSR. It is effective for patients to improve neck pain, stiffness and numbness of both upper limbs, but there is a lack of high-quality clinical evidence to support it. The purpose of this study was to evaluate the efficacy and safety of TLQT in the treatment of CSR. Methods: This is a randomized, double-blind, parallel positive controlled, multi-center clinical trial. 240 patients who met the inclusion criteria were randomly divided into TLQT group and diclofenac sodium plaster group. The treatment period was 3 weeks. Follow-up will be conducted 12 weeks after intervention completion. The main observation index was visual analogue scale (VAS), and the secondary observation index was neck disability index (NDI) and TCM syndrome score. Safety observation indicators will include electrocardiogram, blood tests (including blood routine tests, liver and renal function), routine urine tests, and routine stool tests.The primary and secondary indicators will be performed at 0th, 3th, 7th, 21th and 84th day, and the safety indicators will be performed at 0th, 21th day. Conclusion: This study will provide evidence for the efficacy and safety of TLQT in treating CSR patients. Trial registration:This protocol has been registered in Chinese Clinical Trials Registry. Registration number: ChiCTR2200062271. Registered on 31 July 2022.