Comparative Effectiveness Research of Electroacupuncture and Transcutaneous Electrical Nerve Stimulation in Patients With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Morning stiffness(scoring range 0~10 and lasting time : min/day)
研究概览
简要总结
The aim of this pilot study is to compare the effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation in reducing the tenderness in the patients with rheumatoid arthritis. The study adopted a pragmatic, randomized, patient-centered approach to investigate the effectiveness of clinical symptoms and quality of life.
详细描述
A total of 80 volunteers of patients with rheumatoid arthritis will be recruited from the Chinese medicine or Western medicine clinics in China Medical University Hospital and Dalin Tzu-Chi Hospital. These patients will be randomized to receive electroacupuncture (40 participants) or transcutaneous electrical nerve stimulation (40 participants) treatment two sessions per week and for 10 treatments in total.
The investigators expect that electroacupuncture or transcutaneous electrical nerve stimulation can reduce the severity of pain in the patients with rheumatoid arthritis. The effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation can be detected by visual analogue scale, simplified disease activity index, and disease activity score and be used to improve the clinical symptoms and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-70 years old
- •Met the American College of Rheumatology criteria (2010) for RA
- •Classification of X-ray : Stage I~III
- •The participants' RA medication regimen (DMARD, NSAID, steroid)were eligible if they were on a stable dose for at least 3 months before entry into and throughout the study.
- •All patients were instructed not to make any changes in their background therapies during the study.
- •Intra-articular or pulse steroid were not permitted during the study
排除标准
- •Be treated with biological agents, such as antagonist of TNF-alpha, IL-6, Jak, and CD20 mono antibody in the last 3 months
- •Having history of serious drug allergy
- •Pregnancy or breastfeeding
- •Bleeding or coagulation disorders
- •Localized skin infections
- •Uncontrolled or ill-controlled blood pressure with diastolic pressure≥110 mmHg
- •Any other acupuncture treatment or herbal medication for RA within 2 weeks before screening
- •needle phobia
- •Intra-articular corticosteroid or pulse steroid within 4 weeks preceding the study
- •Any severe chronic or uncontrolled comorbid disease
研究组 & 干预措施
electroacupuncture
The needles remained in situ for 30 minutes, during which time the acupuncturist returned to stimulate the needles once to re-elicit the de qi sensation. Participants have 2 sessions per week, with total 5 weeks and 10 sessions. The body points included LI4, LI11, SP6 and ST36. The individual specific points protocol are as follows: GB20, TE5, SP10, GB34, LV3, ba xie, ba fen, Ashi). The acupuncture protocol consists of the body points and some of the individual specific points depending on subjects' condition.
干预措施: electroacupuncture (Device)
Transcutaneous electrical nerve stimulation
The protocol consisted of first swabbing all points with alcohol, then pads of TENS were sticked on the proper location of acupoints included LI4, LI11, SP6 and ST36. Electrical output of one channel was administered to the surface of body via a combination of two pads. LI4 and LI11, ST36 and SP6 are combination of acupoints, respectively. Participants had 2 sessions per week, with total 5 weeks and 10 sessions. Each session lasted 30 minutes.
干预措施: TENS (Device)
结局指标
主要结局
Morning stiffness(scoring range 0~10 and lasting time : min/day)
时间窗: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
次要结局
- Clinical Disease Activity Index (scoring range 0.0 ~ 76.0)(baseline, week 5, and week 9)
- Simplified disease activity index (scoring range 0.0 ~ 86.0)(baseline, week 5, and week 9)
- Disease Activity Score 28 (scoring range 0.0 ~ 9.4)(baseline, week 5, and week 9)
- Erythrocyte sedimentation rate(baseline, week 5, and week 9)
- Pain Visual Analogue Scale (scoring range 0 ~ 10)(baseline, week 5, and week 9)
- C-reactive protein(baseline, week 5, and week 9)