A Protocol for a Single-Centered, Pragmatic, Randomized, Controlled, Parallel Trial Comparing Comprehensive Nonsurgical Therapy Options for Individuals with Lumbar Spinal Stenosis

Abstract

Ya’nan Sun,1,* Yi An,2,* Xiran Fan,2 Changxin Liu,3 Duoduo Li,3 Yuan Lei,3 Zhiwen Weng,3 Yuanyuan Gong,3 Xiyou Wang,3 Changhe Yu3 1Traditional Chinese Medicine Department, Xuanwu Hospital Capital Medical University, Beijing, People’s Republic of China; 2First Clinical College, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, People’s Republic of China; 3Tuina and Pain Management Department, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, People’s Republic of China*These authors contributed equally to this workCorrespondence: Xiyou Wang; Changhe Yu, Email [email protected]; [email protected]: Lumbar spinal stenosis (LSS) is a long-term degenerative disease. Considering the risks and advantages of the patient’s age range and the characteristics of the condition, non-surgical treatment is recommended. To determine the best first-line non-surgical therapy for LSS, few studies have examined different non-surgical therapies. Therefore, the main objective of this study is to determine whether the selection of comprehensive Chinese medicine (CM) treatment for LSS is more successful than non-surgical conservative treatment.Patients and Methods: In this two-armed, parallel, single-centered, pragmatic randomized controlled study, 94 LSS participants will be randomized to receive 24 sessions of comprehensive CM therapy or conservative treatment for 3 months, with follow-up assessments at 6, 9, 12, and 15 months. The primary outcome will be based on the success rate of the Zurich Claudication Questionnaire (ZCQ) for the most clinical important difference (MCID) at 3 and 15 months. Secondary outcomes include Numerical Rating Scale (NRS) scores for back and leg pain, ZCQ scores, Oswestry Disability Index scores for lumbar dysfunction, and Short-Form 12 scores for health-related quality of life at 3, 6, 9, 12, and 15 months. Adverse events and incidences of surgery will be reported anytime during the trial and follow-up.Conclusion: This protocol examines the comparative efficacy of comprehensive CM therapy compared with conventional care through a pragmatic randomized controlled trial to present data to facilitate clinical or policy decision-making. The outcomes will make it easier to decide which patient-centered treatments to prioritize for LSS.Keywords: lumbar spinal stenosis, Chinese medicine, comprehensive treatment, conservative treatment, pragmatic randomized controlled trial, patient centered

Keywords

• lumbar spinal stenosis
• chinese medicine
• comprehensive treatment
• conservative treatment
• pragmatic randomized controlled trial
• patient centered.