Trial of Auricular Vagus Nerve Stimulation in Painful Covid Long
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
Patients infected with Covid 19 suffer from frequent pain (headache, migraines, joint pain, muscle pain) in the acute phase which may persist after a stay in intensive care or in an intensive care unit, in the event of post-traumatic stress syndrome, pre-existing comorbidities.
The pain mechanisms observed during the covid epidemic are nociceptive / inflammatory pain, neuropathic pain, and nociplastic pain.
Auricular transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic strategy that may reduce inflammation and pain level.
Colosat is a prospective non-randomized pilot feasibility study. Colosat is a 8 weeks non randomized trial investigating the painful Covid long.
tVNS will be performed using a transcutaneous lectrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve.
详细描述
Covid-19 is a disease that presents in several clinical forms (severity and duration). From the end of the first epidemic wave in May 2020, the persistence of symptoms several weeks or months after the first manifestations were described in more than 20% of patients after 5 weeks and more and in more than 10% of patients after 3 months.
In the acute phase, the pains are frequent: headaches / migraines about 13%, joint pain 15%, muscle pain 36%.
In the longer term, patients infected with the coronavirus whose condition necessitated a stay in intensive care have an increased risk of having sequelae (nociceptive or neuropathic) pain. A study carried out 2 years after a stay in an intensive care unit on 164 patients showed that 56% of them suffered from chronic pain. A retrospective study of 80 patients who were hospitalized in the intensive care unit for acute respiratory distress syndrome showed that 38% of them suffered from chronic pain. A meta-analysis of 9 studies and including 1419 patients shows that the incidence or prevalence of pain 3 months after discharge from the intensive care unit ranges from 28 to 77%.
Many viral infections induce neuropathic pain such as Guillain Barré syndrome with an estimated prevalence of 0.5 to 1% and more complex pain syndromes, some of which may suggest nociplastic pain (pain without lesion as in fibromyalgia). There is also a risk of painful chronicization, in particular in the event of post-traumatic stress and / or anxiety-depressive disorders and pre-existing comorbidities (anxiety-depression) There are several pain mechanisms observed during the covid epidemic: nociceptive / inflammatory pain, neuropathic pain, nociplastic pain (without injury).
Pain management is medication with the prescription of analgesics according to the classification of the International Association for the Study of Pain according to the pain-generating mechanism as well as non-drug therapeutic approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects aged 18 to 80 with prolonged post-Covid-19 pain defined by 3 criteria according to the Haute Autorité de Santé :
- •Symptomatic initial episode of Covid-19 is confirmed by at least one criterion among: PCR SARS-CoV-2 +, antigenic test SARS-CoV-2 +, Serology SARS-CoV-2 +, prolonged anosmia / ageusia of sudden onset , chest scanner
- •Presence of at least one of the initial symptoms, beyond 4 weeks following the onset of the acute phase of the disease
- •Initial and prolonged symptoms not explained by another diagnosis with no known link to Covid-19
- •With intact and uninjured skin at the level of the cymba concha of the left ear
- •Signature of informed consent
- •Pain of intensity> or equal to 40 mm / 100mmm on the Visual Analogue Scale (VAS) over the last 7 days before inclusion, analgesic treatment stable for at least 2 weeks
- •Must be able to comply with protocol requirements
- •Beneficiary of a social security scheme or entitled
排除标准
- •Having a hearing aid device with a left cochlear implant
- •Having a major hearing loss
- •Having an unsuitable ear canal
- •Use of other electrically active medical devices (TENS for chronic pain, pacemaker)
- •Taking treatment with strong opioids, corticosteroids or nonsteroidal anti-inflammatory drugs systemically (oral, subcutaneous, intravenous, intramuscular, transdermal).
- •With cognitive disorders that do not allow answering questionnaires and /or setting up the device
- •Known history of cardiac arrhythmias, atrioventricular block> 1st degree, conduction disorders
- •Symptomatic orthostatic hypotension or history of recurrent vagal syncope
- •History of vagotomy
- •severe asthma
- •Pregnant, breastfeeding or having a desire to become pregnant
结局指标
主要结局
Pain
时间窗: 2 months
Difference D0-M2 of self-reported pain post Covid-19 (COVID Long) measured in a 100 mm on a Visual Analog Scale (VAS). The patient assesses the pain of the last eight days before the visit.
次要结局
- Quality of life(1 and 2 months)
- Side effects(1 and 2 months)
- Analgesics(2 months)
- PGIC(2 months)