A Comparative Study of the Effectiveness of Pharmacopuncture Therapy for Chronic Neck Pain: A Pragmatic, Randomized, Controlled Trial

Kyoung-Sun Park, Suna Kim, Changnyun Kim, Ji-Yeon Seo, Hyunwoo Cho, Sang-Don Kim, Yoon-Jae Lee, Jinho Lee, In-Hyuk Ha, Kyoung-Sun Park, Suna Kim, Changnyun Kim, Ji-Yeon Seo, Hyunwoo Cho, Sang-Don Kim, Yoon-Jae Lee, Jinho Lee, In-Hyuk Ha

Abstract

Background: This two-arm, parallel, pragmatic, multicenter, clinical randomized, controlled trial with a 12-week follow-up period aimed to compare the effectiveness of pharmacopuncture therapy and physical therapy strategies for chronic neck pain.

Methods: Eight sessions of pharmacopuncture therapy or physical therapy were administered within 2 weeks. The primary outcome was the visual analogue scale (VAS) score for neck pain. The secondary outcomes were the scores of the Northwick Park questionnaire (NPQ), VAS score for radiating arm pain, numeric rating scale (NRS) for neck and arm bothersomeness, neck disability index (NDI), patient global impression of change (PGIC), 12-item short form health survey (SF-12), and EuroQoL 5-dimension 5-level (EQ-5D-5L) instrument. The protocol was registered with Clinicaltrials.gov (NCT04035018) and CRIS (KCT0004243).

Results: We randomly allocated 101 participants with chronic neck pain to the pharmacopuncture therapy (n = 50) or physical therapy group (n = 51). At the primary endpoint (week 5) the pharmacopuncture therapy group showed significantly superior effects regarding VAS score for neck pain and arm bothersomeness, NRS for neck pain, NDI, NPQ, and PGIC compared with the physical therapy group. These effects were sustained up to 12 weeks after follow-up.

Conclusion: Compared with physical therapy, pharmacopuncture therapy had superior effects on the pain and functional recovery of patients with chronic neck pain.

Keywords: acupuncture; neck pain; pharmacopuncture; physical therapy; pragmatic clinical trial; randomized controlled trial.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of the study. VAS, visual analogue scale; PT, physical therapy.
Figure 2
Figure 2
Changes in outcomes over time and areas under the curves. All graphs show the changes in scores for outcomes related to quality of life and physical function during the 12 weeks after randomization. (A) VAS score for neck pain; (B) VAS score for arm pain; (C) NRS score for neck pain; (D) NRS score for arm pain; (E) NDI score; (F) NPQ score. The dots show the mean scores and error bars show the 95% confidence intervals. Missing values were added using multiple imputation. VAS, visual analogue scale; NRS, numeric rating scale; NDI, neck disability index; NPQ, Northwick Park questionnaire.
Figure 3
Figure 3
Cumulative incidence curves of recovery by group. (A) VAS scores and (B) NRS scores for neck pain at 11 weeks. A survival analysis based on the recovery of patients with ≥50% reduction in neck pain revealed that the pharmacopuncture group had a faster recovery rate than the PT group over the course of 11 weeks (p < 0.001, log-rank test). The HRs for the number of patients with ≥50% reduction in neck pain at week 12 were 4.31 and 3.24 for the VAS (95% CI: 2.11–8.82) and NRS (95% CI: 1.78–5.90), respectively, with the pharmacopuncture group showing favorable results. VAS, visual analogue scale; NRS, numeric rating scale; PT, physical therapy; HR, hazard ratio; CI, confidence interval.

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