Xia Chun-Ya, Niu Hao-Zhi, Zhang Xin-Wen, Cai Si-Yan, Fan Ying-Jie, Xie Tian-Pei, Dong Peng-Xia, Zu Xiao-Tong, Su Ze-Lin, Lu Xing-Sheng, Hao Yong-Gang, Su Min
Department of Physical Medicine and Rehabilitation, The Fourth Affiliated Hospital of Soochow University (Dushu Lake Hospital Affiliated to Soochow University), Suzhou, China.
Department of Rehabilitation Medicine, Rehabilitation Institute of Soochow University, Suzhou, China.
BMC Musculoskelet Disord. 2025 Jul 15;26(1):684. doi: 10.1186/s12891-025-08924-1.
To evaluate the efficacy of wearable transcutaneous electrical nerve stimulation (TENS) combined with transcranial direct current stimulation (tDCS) in the middle-aged person with mild knee osteoarthritis (KOA).
Double-blind, randomized clinical trial.
A general hospital.
Participants aged 60-70 with mild KOA (Kellgren-Lawrence grade 1-2).
The experimental group received TENS + tDCS, and the control group received TENS + sham tDCS for four weeks from Monday through Friday.
The primary outcome was Brief Pain Inventory (BPI). The secondary outcomes included participants' Visual Analog Scale (VAS), step length, cadence, 6-minute walking test (6MWT), active knee range of motion (ROM), and quadriceps strength. The indexes were assessed one week before treatment (T0), two weeks after treatment commencement (T1), four weeks after treatment commencement (T2), one month after treatment cessation (T3), and two months after treatment cessation (T4).
A total of 110 participants (55 per group) completed the intervention and follow-up. Repeated-measures ANOVA indicated that tDCS significantly improved the efficacy of TENS in alleviating pain and enhancing walking ability among patients with mild KOA. Statistically significant differences in BPI scores were observed between the experimental and control groups at T1 (2.16 vs. 2.45, P = 0.038), T2 (1.17 vs. 1.73, P < 0.001), and T3 (2.17 vs. 2.41, P = 0.021). However, no significant difference was detected at T4 (2.50 vs. 2.63, P = 0.293).
The four-week combined intervention demonstrated that tDCS potentiated the therapeutic efficacy of TENS in managing mild KOA. The combined protocol exhibited superiority over TENS monotherapy, with sustained benefits observed up to one-month post-intervention.
This research has been registered in chictr.org.cn (registration number: ChiCTR2200064735) on 15 October 2022, https://www.chictr.org.cn/showproj.html?proj=182561 .
评估可穿戴式经皮电刺激神经疗法（TENS）联合经颅直流电刺激（tDCS）对中年轻度膝骨关节炎（KOA）患者的疗效。
双盲随机临床试验。
一家综合医院。
年龄在60 - 70岁之间的轻度KOA患者（Kellgren-Lawrence分级为1 - 2级）。
实验组接受TENS + tDCS治疗，对照组从周一至周五接受TENS + 假tDCS治疗，为期四周。
主要结局指标为简明疼痛量表（BPI）。次要结局指标包括参与者的视觉模拟评分法（VAS）、步长、步频、6分钟步行试验（6MWT）、膝关节主动活动范围（ROM）和股四头肌力量。在治疗前一周（T0）、治疗开始后两周（T1）、治疗开始后四周（T2）、治疗结束后一个月（T3）和治疗结束后两个月（T4）对各项指标进行评估。
共有110名参与者（每组55名）完成了干预和随访。重复测量方差分析表明，tDCS显著提高了TENS对轻度KOA患者缓解疼痛和增强步行能力的疗效。在T1（2.16对2.45，P = 0.038）、T2（1.17对1.73，P < 0.001）和T3（2.17对2.41，P = 0.021）时，实验组和对照组的BPI评分存在统计学显著差异。然而，在T4时未检测到显著差异（2.50对2.63，P = 0.293）。
为期四周的联合干预表明，tDCS增强了TENS治疗轻度KOA的疗效。联合方案优于TENS单一疗法，在干预后长达一个月内均观察到持续益处。
本研究已于2022年10月15日在chictr.org.cn上注册（注册号：ChiCTR2200064735），https://www.chictr.org.cn/showproj.html?proj=182561 。
