Interest of the Association of Two Complementary Techniques, Hypnosis and Transcutaneous Electrical Nerve Stimulation in the Treatment of Chronic Non-cancer Pain, Nociceptive and / or Neuropathic Pain: Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
At Saint-Antoine's hospital, in CETD a multidisciplinary team takes care of patients with chronic pain. Free-drug techniques are available to reduce their consumption of analgesics. This study is to assess the relief obtained by the simultaneous combination of these two techniques: transcutaneous electrical nerve stimulation and hypnosis.
详细描述
In the pain management centers, patients with chronic pain are supported by a multidisciplinary team. To optimize and reduce drug intake of analgesics, additional techniques (hypnosis, relaxation, cognitive behavioral therapy) and non-drug practices (transcutaneous electrical nerve stimulation) are offered to patients.
These techniques are most frequently performed by nurses and are used either separately or successively. The time interval during what the patient could expect pain relief is not known.
The hypothesis of the study is that simultaneous practice of two complementary therapies (transcutaneous electrical nerve stimulation (TENS) + hypnosis) decreases the intensity of pain in patients with chronic no cancer pain, nociceptive and/or neuropathic pain compared to practice of only one complementary therapy (TENS).
This study is an open randomized trial, comparative in two parallel groups (TENS versus TENS and hypnosis).
Trial design will be explained by the pain management center doctor. Inclusion and randomization performed by the nurse: group with TENS/group with TENS and hypnosis.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 18 to 80 years suffering from chronic no cancer pain either nociceptive or neuropathic.
- •The treated skin must not be wounded
- •The patients must be able to comply with the requirement of the trial; they also need to express no objection to participate to this trial.
- •Patient with social security
排除标准
- •Patients with fibromyalgia, or having relaxation therapy sessions, acupuncture, cognitive and behavioral therapies
- •Patients with cognitive disorders, an unaided hearing loss, a major hearing impairment, carrying a pace maker, having an allodynia or a complete anesthesia of the painful territory, a large spreader painful territory
- •Sessions TENS practiced for analgesic by a professional within 3 years prior to inclusion, for the same pain (same features, same location)
- •Renting at home a TENS device within 3 years prior to inclusion for analgesic
- •Prior therapeutic care by hypnosis
- •pregnant woman or having a desire of pregnancy
结局指标
主要结局
Pain intensity
时间窗: between the first visit and three months after the beginning of the strategy.
The pain assessment is processed using a Visual Analog Scale (VAS), graduated from 0 to 100mm. The patient is asked to move a cursor on a line to reflect the severity of his/her pain. The left end indicates "no pain", the right one shows "the most intense pain you can imagine". On the other side, graduations are only seen by the caregiver. The pain intensity is read on this side, rated in millimetres.
次要结局
- the patient's observance with the different strategies using a pad.(from one week after the beginning of the strategy up to 6 months.)
- the quality of life estimated by the patient using the scale(ladder) SF36 and estimating the impression(printing) of change of the patient using the PGIC scale(ladder)(at the first visit, one month, three and six months after the beginning of the strategy, except the scale QDSA, which is used one, three and six months later after the beginning of the strategy.)
- the consumption of analgesic(during 6 months.)