Clinical research for whether the Traditional Chinese medicine could promote the resorption of lumbar disc herniation: a randomized controlled trial

Abstract

Lumbar disc herniation (LDH) is a common, disabling musculoskeletal disorder. Magnetic resonance imaging has clarified the natural history of lumbar disc lesions and has documented that disc lesions can become smaller and can even be completely resorbed. Previous studies have confirmed that some traditional Chinese medicine (TCM) therapies can promote resorption of the protrusion. However, high-quality research evidence is needed to support the effectiveness of the protocol.

Objective:

This clinical trial aims to establish whether TCM can promote the resorption of LDH and to assess the efficacy of such therapy for LDH, thereby evaluating its clinical effect.

Methods:

The present study design is for a single-center, 2-arm, open-label randomized controlled trial. A total of 150 eligible LDH patients will be randomly assigned to either a TCM treatment group or a control group in a 1:1 ratio. Patients in the TCM group will be administered a TCM decoction for 4 weeks. Patients in the conventional drug control group will be instructed to take a specific daily dose of celecoxib. The primary outcome measure is the change from baseline in the volume of the protrusion, as assessed using MR images. Secondary outcome measures include visual analog scale pain scores and Japanese Orthopaedic Association scores assessed at 3 and 6 months.

Discussion:

The design and methodological rigor of this trial will allow evaluation of the basic clinical efficacy and safety data for TCM in the treatment of patients with LDH. The trial will also assess whether TCM can promote the resorption of LDH. This research will therefore help provide a solid foundation for the clinical treatment of LDH and for future research in TCM therapy.

Trial registration:

ChiCTR1900022377.