Park Kyoung-Sun, Kim Suna, Kim Changnyun, Seo Ji-Yeon, Cho Hyunwoo, Kim Sang-Don, Lee Yoon-Jae, Lee Jinho, Ha In-Hyuk
Jaseng Hospital of Korean Medicine, Seoul 06110, Korea.
Daejeon Jaseng Hospital of Korean Medicine, Daejeon 35262, Korea.
J Clin Med. 2021 Dec 21;11(1):12. doi: 10.3390/jcm11010012.
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.
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).
We randomly allocated 101 participants with chronic neck pain to the pharmacopuncture therapy ( = 50) or physical therapy group ( = 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.
Compared with physical therapy, pharmacopuncture therapy had superior effects on the pain and functional recovery of patients with chronic neck pain.
这项双臂、平行、实用、多中心、临床随机对照试验,随访期为12周,旨在比较药物穴位注射疗法和物理治疗策略对慢性颈痛的疗效。
在2周内进行8次药物穴位注射疗法或物理治疗。主要结局指标为颈部疼痛的视觉模拟量表(VAS)评分。次要结局指标包括诺斯威克公园问卷(NPQ)评分、放射至手臂疼痛的VAS评分、颈部和手臂困扰的数字评定量表(NRS)、颈部功能障碍指数(NDI)、患者整体变化印象(PGIC)、12项简明健康调查(SF-12)以及欧洲五维健康量表(EQ-5D-5L)。该方案已在Clinicaltrials.gov(NCT04035018)和CRIS(KCT0004243)注册。
我们将101例慢性颈痛患者随机分配至药物穴位注射疗法组(n = 50)或物理治疗组(n = 51)。在主要终点(第5周),与物理治疗组相比,药物穴位注射疗法组在颈部疼痛和手臂困扰的VAS评分、颈部疼痛的NRS评分、NDI、NPQ和PGIC方面显示出显著更好的效果。这些效果在随访至12周时仍持续存在。
与物理治疗相比,药物穴位注射疗法对慢性颈痛患者的疼痛和功能恢复具有更好的效果。