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A Protocol for a Single-Centered, Pragmatic, Randomized, Controlled, Parallel Trial Comparing Comprehensive
Ya'nan Sun1, Yi An2, Xiran Fan2
1Traditional Chinese Medicine Department, Xuanwu Hospital Capital Medical University, Beijing, People's Republic of China.
Journal of Pain Research
|March 16, 2023
Summary
This study compares comprehensive Chinese medicine (CM) with conservative care for lumbar spinal stenosis (LSS). It aims to determine if CM offers a more successful non-surgical treatment option for LSS patients.
Area of Science:
- Integrative Medicine
- Orthopedics
- Clinical Trials
Background:
- Lumbar spinal stenosis (LSS) is a degenerative condition often managed non-surgically.
- Optimal first-line non-surgical treatments for LSS require further investigation.
- Patient age and condition characteristics influence treatment recommendations.
Purpose of the Study:
- To compare the efficacy of comprehensive Chinese medicine (CM) versus conventional conservative treatment for LSS.
- To provide data for clinical and policy decision-making regarding LSS management.
- To identify patient-centered treatments for prioritizing LSS care.
Main Methods:
- A pragmatic randomized controlled trial involving 94 LSS participants.
- Two arms: comprehensive CM therapy (24 sessions over 3 months) versus conservative treatment.
- Primary outcome: Zurich Claudication Questionnaire (ZCQ) success rate at 3 and 15 months.
Main Results:
- The study protocol is designed to collect data on comparative efficacy.
- Secondary outcomes include pain scores (NRS), lumbar dysfunction (ODI), and quality of life (SF-12).
- Adverse events and surgical interventions will be monitored throughout the trial and follow-up period.
Conclusions:
- This trial will evaluate the comparative effectiveness of CM for LSS.
- Results will inform decisions on prioritizing patient-centered LSS treatments.
- Data will support clinical practice and healthcare policy for LSS management.
