Effectiveness of Noninvasive Neuromodulation in Post-COVID Musculoskeletal Pain in the Short Term: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Brief Summary:
The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related.
Non-invasive neuromodulation acts on the Central Nervous System through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances.
The objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-Covid musculoskeletal pain. Subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. The variables to be studied before, during and after treatment will be neuropathic pain with the DN4 questionnaire, pain intensity with the EVA scale, sleep quality with the Pittsburgh Sleep Quality Index, level of stress and anxiety with the HADS questionnaire and quality of life with the SF12.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive result in PCR or antigen test for detecting COVID-19 in the last 3 months.
- •Present musculoskeletal pain in the last 3 months.
- •Age between 18 to 65 years old.
- •Score equal or superior to 4 in DN4 scale.
排除标准
- •Present musculoskeletal pain of traumatic origin or known cause
- •Present musculoskeletal pain with more than 3 months of evolution.
- •Pregnant women
- •Present of vascular alterations, malignancy, thrombophlebitis or fever.
研究组 & 干预措施
Neuromodulation experimental group
The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks.
The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes.
干预措施: Neuromodulation group (Other)
Neuromodulation sham group
The total number of sessions to be carried out on each patient will be 12 sessions, spread over 4 weeks.
The frequency will be 3 times a week. Each session with NESA microcurrents will last 60 minutes.The treatment will be applied with a placebo device that does not emit microcurrent but that has the same function
干预措施: Neuromodulation sham group (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Change from Baseline at one month.
VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health), orientated from the left (worst) to the right (best)
次要结局
- DN4 scale(Change from Baseline at one month.)
- Pittsburg Sleep Quality Index score(Change from Baseline at one month.)
- Hospital Anxiety and Depression Scale (HAND)(Change from Baseline at one month)
- Quality of life SF12(Change from Baseline at one month.)
研究者
Prof. Dr. Daniel Pecos Martín
Professor
University of Alcala