Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study

Abstract

Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

Keywords: acupotomy; epidural steroid injection; integrative medicine; pilot projects; radiculopathy; randomized controlled trial.

Figure 1

Location of the Hyeopcheok acupoint (EX-B2 L1-5). Each blue circle indicates the location of EX-B2 in the lumbar spine. EX-B2 is the international standard nomenclature for Hyeopcheok acupoints.

Figure 2

CONSORT flowchart of participant enrollment. Abbreviations: DAH, deeply inserted acupotomy to Hyeopcheok acupoints; ESI, epidural steroid injection; ITT, intention-to-treat.

Figure 3

Line graph of changes from baseline between the experimental and control groups. Green, DAH + ESI treatment group; Blue, ESI single-treatment group. * p < 0.05, ** p < 0.01. Abbreviations: DAH, deeply inserted acupotomy to Hyeopcheok acupoints; EQ-5D, European Quality of Life 5 Dimensions; ESI, epidural steroid injection; MPQ, McGill Pain Questionnaire; ODI, Oswestry Disability Index; RMDQ, Roland–Morris Disability Questionnaire; VAS, visual analog scale.