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

Ya'nan Sun; Yi An; Xiran Fan; Changxin Liu; Duoduo Li; Yuan Lei; Zhiwen Weng; Yuanyuan Gong; Xiyou Wang; Changhe Yu

doi:10.2147/JPR.S398897

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

J Pain Res. 2023 Mar 9:16:773-784. doi: 10.2147/JPR.S398897. eCollection 2023.

Authors

Ya'nan Sun^#¹, Yi An^#², Xiran Fan², Changxin Liu³, Duoduo Li³, Yuan Lei³, Zhiwen Weng³, Yuanyuan Gong³, Xiyou Wang³, Changhe Yu³

Affiliations

¹ Traditional Chinese Medicine Department, Xuanwu Hospital Capital Medical University, Beijing, People's Republic of China.
² First Clinical College, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.
³ Tuina and Pain Management Department, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, People's Republic of China.

^# Contributed equally.

Abstract

Aim: 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: Chinese medicine; comprehensive treatment; conservative treatment; lumbar spinal stenosis; patient centered; pragmatic randomized controlled trial.

Grants and funding

No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. Changhe Yu is funded for this work by a the National Natural Science Foundation of China (Grant No. 81803956); Capital Health Development Research Project (No. 2020-4-4195); Seed Funding of Golden Bridge Project of Beijing Municipal Science and Technology Commission (No. ZZ21053). The funders had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the article; or in the decision to publish the results.