Background: Long-term effects of individualized acupuncture in persons with chronic neck pain (CNP) remain unknown.
Objective: To evaluate the efficacy and safety of pressure pain, sensory-based individualized acupuncture for relieving CNP.
Design: A 24-week multicenter randomized controlled clinical trial. (ChiCTR1800016371).
Setting: Outpatient settings at 4 clinical centers in China from May 2018 to March 2020.
Participants: 716 participants with CNP.
Intervention: Participants were randomly assigned to a waiting list (WL) group or to 1 of 3 interventions, which consisted of 10 sessions over 4 weeks: higher sensitive acupoints (HSA), lower sensitive acupoints (LSA), and sham acupoints (SA) acupuncture groups.
Measurements: The primary outcome was the change in the visual analogue scale (VAS) score for neck pain (range, 0 to 100) from baseline to 4 weeks, with a difference of 10 points considered the minimum clinically important threshold. The VAS was also assessed every 4 weeks through 24 weeks.
Results: The modified intention-to-treat population included 683 participants. The mean baseline VAS was 50.36, 50.10, 49.24, and 49.16 for HSA, LSA, SA, and WL, respectively. Compared with a mean baseline to week 4 change of -12.16 in the HSA group, the mean changes were -10.19 in the LSA group (net difference [ND], -1.97 [95% CI, -5.03 to 1.09]), -6.11 in the SA group (ND, -6.05 [CI, -9.10 to -3.00]), and -2.24 in the WL group (ND, -9.93 [CI, -12.95 to -6.90]). The intervention effects persisted at 24-week follow-up.
Limitation: Lack of complete blinding and limited generalizability.
Conclusion: Individualized acupuncture interventions using high- or low-sensitivity acupuncture points were more effective in reducing CNP than SA and WL control groups sustained through 24 weeks, but the magnitude of relative improvement did not reach a minimal clinically important difference.
Primary funding source: National Natural Science Foundation of China.