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

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:

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

Abbreviations

LSS, Lumbar spinal stenosis; NC, Neurogenic claudication; CC, conservative care; CM, Chinese medicine; CMG, CM group; CCG, CC group; CHM, Chinese herbal medicine; PPI, patient and public engagement; TENS, Transcutaneous Electrical Nerve Stimulation; ESI, epidural steroid injection; NSAID, Nonsteroidal anti-inflammatory drug; ZCQ, Zurich Claudication Questionnaire; NRS, Numeric Rating Scale; ODI, Oswestry Disability Index; SF-12, Short-Form 12 for Health-Related Quality of Life.

Ethical Approval

The study has been approved by the Ethics Committee the Dongzhimen hospital of Beijing University of Chinese Medicine (2021DZMEC-123-02).

Consent

Written informed consent will be obtained from all participants. All personal information about potential and enrolled participants will be confidential.

Acknowledgments

We acknowledge all the colleagues and staff at Tuina and pain management department of Dongzhimen Hospital. This study was funded by 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).

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors declare that they have no conflicts of interest.

Additional information

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.