Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer. Evaluation in Patients With Peripheral Osteoarthritis: A Single Center, Prospective, Randomized in Cross-over, Comparative and Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of pain (evaluates with visual analogue scale ) with and without the use of medical device in patients with peripheral osteoarthritis who benefit from their conventional pain treatment.
研究概览
简要总结
In this study, in addition of conventional treatment, the efficacy of the medical device, Remedee One, in medical care of patients with peripheral osteoarthritis pain is evaluated.
详细描述
Osteoarthritis affects 10 millions people in France (17% of the population). It's the second cause of disability and consultation after the cardiovascular diseases in France. For the moment, there is no curative treatment for osteoarthritis The main clinical sign of this disease is pain and care is based on the treatment of pain and on the improvement of functionnal disability. The proposed treatments are mainly based on the use of oral analgesics treatments .
At present, patients report to be insufficiently relieved. New strategies need to be developed. The hypothesis is that the use of an innovative medical device, Remedee One, can reduce the pain felt by patients, improve their quality of life and reduce the analgesics consumption.
The choice is oriented on the peripheral osteoarthritis and excludes spinal osteoarthritis because it's an osteoarthritis always asymptomatic and painless.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 50 years
- •Patient followed in rhumatology consultation or at the center of the pain of the University Hospital of Grenoble or in liberal for peripheral osteoarthritis (ankle, knee, hip, shoulder, elbow, digital) clinically and radiologically confirmed according to the recommendations of the American College of Rheumatology.
- •Patient with a pain score on a Visual Analog Scale (VAS) ≥ 4 on a numerical scale of 0 to 10 (average VAS intensity over the week prior to the inclusion visit),
- •Patient with a stable analgesic treatment without introduction of a new therapeutic class within the last 3 months,
- •Patient with a wrist size compatible with the size of the medical device
- •Patient affiliated to social security or beneficiary of such a scheme.
- •Having signed a consent to participate.
排除标准
- •Patient with chronic inflammatory joint disease (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic rheumatism, spondyloarthritis, lupus),
- •Patient who received an intra-articular corticosteroid injection within 3 months prior to inclusion,
- •Patient with surgery scheduled within the next eight months,
- •Patient presenting at both wrists a dermatological pathology such as oozing dermatosis, hyper sweating or an unhealed lesion,
- •Patient having a piercing or implanted metallic material on both wrists,
- •Patient with a tattoo on both wrists,
- •Patient deprived of liberty by judicial or administrative decision
- •Patient subject to legal protection or unable to express his consent (guardianship or curatorship)
- •Patient in exclusion period of another interventional study
结局指标
主要结局
Comparison of pain (evaluates with visual analogue scale ) with and without the use of medical device in patients with peripheral osteoarthritis who benefit from their conventional pain treatment.
时间窗: 7 months
At the end of each month for each period of the cross-over, the pain is evaluated using a visual analogue scale (VAS).
次要结局
- Comparison of quality of life (evaluated with the EQ5D5L questionnaire), with and without the use of the medical device, in patients with peripheral osteoarthritis who benefit from their conventional pain treatment.(7 months)
- Comparison of depressive state and coping (evaluated with the HAD questionnaire), with and without the use of the medical device in patients with peripheral osteoarthritis receiving their conventional pain treatment..(7 months)
- Adverse effect from the medical device.(7 months)
- Charaterization of the sleep quality (evaluated with a qualitative visual satisfaction scale) with and without the use of medical device in patients with peripheral osteoarthritis and benefiting from their conventional pain treatment.(7 months)
- Medical device acceptability : descriptive analysis(7 months)
- Number of analgesic consumption, with and without the use of the medical device, in patients with peripheral osteoarthritis and benefiting from their conventional pain treatment.(7 months)
- Number of care consumption with and without the use of the medical device in patients with peripheral osteoarthritis and benefiting from their conventional pain treatment.(7 months)
- Comparison of functional capacity (evaluated with the WOMAC questionnaire) with and without the use of the medical device in patients suffering from osteoarthritis of the lower limbs and benefiting from their conventional pain treatment.(7 months)
- Comparison of the functional capacity (evaluatet with the DREISER questionnaire) with and without the use of the medical device in patients with digital osteoarthritis and benefiting from their conventional pain treatment.(7 months)
- Description of the medical device use(7 months)