A Pragmatic Randomized Controlled Trial on the Effectiveness and Safety of Pharmacopuncture for Chronic Lower Back Pain

Abstract

Purpose

Chronic lower back pain (LBP) is a major global health concern. Pharmacopuncture has been widely used to treat LBP in Korea; however, randomized clinical trials (RCT) or active control have not been conducted to evaluate its effectiveness. Therefore, this RCT aimed to compare the effectiveness of pharmacopuncture and physical therapy (PT) for the treatment of chronic LBP.

Patients and Methods

A two-arm, parallel, and multicenter RCT was conducted at four hospitals of Korean medicine. Participants with chronic LBP were randomly assigned at a 1:1 ratio using block randomization to undergo 10 sessions of pharmacopuncture or PT over 5 weeks and followed up for 25 weeks. The numerical rating scale (NRS) and visual analog scale scores of LBP and radiating leg pain and the Oswestry disability index (ODI), 5-level EuroQol-5 dimension (EQ-5D-5L), and the patient global impression of change were recorded at baseline and at 6, 13, and 25 weeks. An intention-to-treat analysis was conducted as the primary analysis using a linear mixed model.

Results

One-hundred patients (mean age, 49.27 years; 58 women) were recruited. At 6 weeks after randomization, pharmacopuncture showed statistically superior results compared with PT in LBP (difference in NRS, 1.54; 95% CI, 0.94–2.13), function (difference in ODI, 4.52%; 95% CI, 0.93–8.11%), and quality of life (difference in EQ-5D-5L) scores (−0.05; 95% CI, −0.08 to −0.01). This effect persisted for 25 weeks. In the survival analysis for participants with at least a 50% reduction in the NRS scores of LBP during the 182-day follow-up, the pharmacopuncture group showed significantly faster recovery than the PT group (P<0.001, Log rank test).

Conclusion

Pharmacopuncture significantly reduced pain and improved functional outcomes and quality of life in patients with low back pain compared with physical therapy. Based on the findings of this study, pharmacopuncture could be recommended as a treatment for patients with chronic low back pain.

Keywords:

• low back pain
• pharmacopuncture
• physiotherapy
• Oswestry disability index
• Roland–Morris disability questionnaire
• pragmatic randomized controlled trial

Data Sharing Statement

The data presented in this study are available upon request from the corresponding author.

Acknowledgments

We would like to thank all individuals who participated in the study, including the patients and clinical research coordinators.

Author Contributions

All authors made a substantial contribution to the work reported, including the conception, study design, execution, acquisition of data, analysis, and/or interpretation; participated in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; agreed on the journal to which the article was submitted; and accept responsibility for all aspects of the work.

Disclosure

The authors declare that they have no competing interests.

Additional information

Funding

This research was funded by the Korea Institute of Oriental Medicine, Republic of Korea (grant number: KSN1823211). This research project was an investigator-initiated trial in which the investigator played a leading role in the study design, performance of the trial, analyses, data interpretation, and report writing.