Randomized, Double-Blind, Placebo-Controlled Trial, Parallel Design Used To Evaluate Pain, Endocrinologic Variations, Life Quality And Medication Use, After Electro-Acupuncture Treatment In Patients With Osteoarthritis Of The Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale
研究概览
简要总结
The purpose of this study is to assess the efficacy of electroacupuncture (EA) on pain control, perception of pain, plasma cortisol and beta-endorphins levels, patient-perceived quality of life and use of pain medications, in people with chronic knee pain.
详细描述
Previous randomised trials and meta-analyses have shown certain efficacy of acupuncture in some chronic painful conditions, in spite of methodological weaknesses. The hypothalamic-pituitary-adrenal (HPA) axis and the endogenous opioid (EO) system are the mechanisms appear to explain how acupuncture works in part. These systems have been shown to be important mediators of stress, pain and other stimuli. The Osteoarthritis Research International suggest that osteoarthritis (OA) treatment should be multidisciplinary and recommended acupuncture as one of 12 possible non-pharmacological modalities for treating OA.
This study is a randomized, double-blind, placebo-controlled trial, parallel design. 128 out-patients over 50 years with OA of the knee will be recruited from Mallorca, Spain. Participants will be randomly allocated into two groups: placebo/sham acupuncture, non insertion technique, and EA. Acupuncture treatments will be used the Traditional Chinese Medicine (TCM) style. The patients will be evaluated after a period of one month (2 sessions weekly), three months (1session monthly), six months (1 session every 45 days) and again one year later (1 session every 2 months), at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
- •Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 and chronic pain in the knee joint for more than 3 months.
排除标准
- •The patients with secondary osteoarthritis of knees
- •Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
- •Patients on steroids
- •Disease modifying drugs, e.g. methotrexate and azathioprine
- •Patients with recent trauma in the area of acupuncture
- •History of intra articular injection of steroid within last two months
- •Patients missing two or more sessions of electro-acupuncture consecutively were excluded from the study
结局指标
主要结局
Changes from baseline in visual analogue scale (VAS) and the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index pain subscale
时间窗: baseline and the completion of treatment at 12 weeks.
a continuous scale comprised of a horizontal line, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 \[100-mm scale\]). (VAS pain intensity score)
次要结局
- Change from Baseline in Goldberg Depression and Anxiety scales(up to 1 year)
- Changes from baseline in The Short Form 36 version 2 (SF-36v2) health survey(up to 1 year)
- Change from baseline in plasma cortisol and beta-endorphins levels(up to 1 year)
- Changes in baseline use of medication(up to 1 year)
- Change from baseline in WOMAC index(up to 1 year)
- Change from baseline in a visual analogue scale (VAS)(up to 1 year)
研究者
Javier Mata
Chief of Section of Anesthesiology and Reanimation Department
Hospital Son Llatzer