Effectiveness and Safety of Acupotomy on Lumbar Spinal Stenosis: A Pragmatic, Pilot, Randomized Controlled Trial

Abstract

Purpose

In Korea, complex treatments such as acupotomy, acupuncture, and physical therapy are performed for lumbar spinal stenosis (LSS). Although there are reports of acupotomy as monotherapy or acupuncture treatment for LSS, pragmatic studies are lacking. Therefore, this study aimed to determine the effectiveness and safety of acupotomy for LSS to provide baseline evidence for a large-scale study.

Materials and Methods

This pragmatic randomized controlled pilot study enrolled 34 participants and randomly assigned them to two groups (n=17/group). The intervention was conducted for 8 weeks. Acupotomy plus and usual care groups received acupuncture (17 acupoints) and interferential current therapy (ICT) twice weekly; however, the acupotomy plus group received an additional acupotomy (7 acupoints) for treatment of the usual care group. The primary outcome was measured using visual analog scales (VAS), and secondary outcomes were assessed using the self-rated walking distance, short-form McGill Pain Questionnaire (SF-MPQ), and the Oswestry Disability Index (ODI). Outcome measurements were conducted at baseline and 4, 8, and 12 weeks after the commencement of the intervention. Adverse events were assessed at each visit. Hematological and biochemical examinations were performed at screening and week 8.

Results

Overall, 33 of the 34 participants completed the study, and one participant in the usual care group dropped out. In both groups, VAS scores at weeks 4, 8, and 12 significantly improved compared to baseline. Also, self-rated walking distance, SF-MPQ, and ODI scores were significantly improved at weeks 4, 8, and 12 than at baseline. However, there were no significant differences in the time-dependent and group-to-time interactions between the two groups. In addition, no severe adverse reactions were reported, and there were no significant differences in hematological and biochemical results.

Conclusion

This study provides baseline data for large-scale studies on the effectiveness and safety of acupotomy in LSS.

Clinical Trial Number

KCT0006234.

Keywords:

• complementary therapy
• pragmatic clinical trial
• low back pain
• acupuncture therapy

Abbreviations

ICT, interferential current therapy; ITT, intention-to-treat; LSS, Lumbar spinal stenosis; ODI, Oswestry Disability Index; PPI, present pain index; SF-MPQ, short-form McGill Pain Questionnaire; VAS, visual analog scales.

Data Sharing Statement

All available data from this trial are presented in the article. We would welcome any third-party scrutiny, and interested parties should contact the corresponding author.

Ethics Approval and Informed Consent

This trial was approved by the Institutional Review Board of Daegu Oriental Hospital, Daegu Haany University (DHUMC-D-21001-ANS-01), and registered at CRIS (KCT0006234). Participants signed an informed consent form after explaining the intervention process during the trial period.

Consent for Publication

All study participants provided consent for publication in this journal.

Acknowledgments

This study was financially supported by grants from the project KSN1823211 of the Korea Institute of Oriental Medicine (KIOM), Republic of Korea.

Author Contributions

All authors made a significant contribution to this 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 report no conflicts of interest in this work.