Physiotherapy for Persistent Function by Superficial Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pain Pressure Threshold
研究概览
简要总结
Objectives:
To evaluate pressure pain thresholds, fatigue scales, quality of life and sleep quality, in women with Persistent Covid (PC), pre- and post-treatment using electrotherapy and in a placebo group of PC patients.
Relevance:
This trial can be a tool for patients affected by CP who present pain and fatigue problems, insomnia or signs of imbalance of their Autonomic Nervous System. It aims to improve their rest and recovery for a better quality of life that allows them to recover their Activities of Daily Living.
We have designed the study with a commitment to placebo group treatment after completion, if positive results are obtained.
A 6-month and 1-year follow-up will be scheduled.
Secondary objectives:
To analyze the effects on quality of life, fatigue and sleep. To analyze the presence of cardiac variability and pre- and post-treatment cortisol values.
Patients and Methods:
12 patients with CP will receive 15 sessions of electrotherapy. 12 will receive a placebo.
Mechanical sensitivity pre-post, by means of an algometer, cardiac variability, cortisol levels, and other variables, will be measured by means of questionnaires.
Mechanical sensitivity to pain will be measured using an algometer (Baseline 12-0300 MMT). Patients will be instructed to report when the sensation of pressure changes to pain.
The pre-post electrotherapy treatment described above will be measured, the differences in mechanical sensitivity, pain threshold to pressure, the Pittsburg questionnaires, SF-36, MFIS and EQooL-5.
Follow-up will be done at 6 months and at one year. The study design is a triple-blind randomized controlled clinical trial. Patients who sign the consent form will be evaluated by an internist who will perform a physical examination at the clinic of the Faculty of Nursing and Physiotherapy of the Pontifical University of Salamanca (UPSA).
The sample will be randomized. 12 patients will receive treatment and 12 patients will receive a placebo. With a commitment to treat these patients in the event that positive results are obtained after the end of the study.
A biphasic microcurrent will be applied with a frequency between 1.14 Hertz and 14.29 Hertz and intensities between 0.1 and 0.9 mA.
Frequency: 2 times a week. A total of 15 sessions in 7.5 weeks. The session time with microcurrents will last 60 minutes.
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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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have had symptoms of PC for more than one year.
- •Signs of central sensitization.
排除标准
- •Previous treatment with surgery.
- •Previous spinal trauma.
- •Whiplash.
- •Pregnancy situation.
- •Previous musculoskeletal disease (rheumatoid arthritis, sympathetic-reflex dystrophy, fibromyalgia).
- •Pacemaker.
- •Electric drug pump.
- •Skin sensitivity alterations.
- •Analgesic or anxiolytic drug treatment during the study.
研究组 & 干预措施
Experimental group
A two-phase microcurrent with a frequency between 1.14 Hertz and 14.29 Hertz and currents between 0.1 and 0.9 mA will be applied.
A total of 15 sessions in 7.5 weeks. Twice a week. The session time with microcurrents will last 60 minutes.
干预措施: Neuromodulation NESA NXSIGNAL® device (Device)
Placebo group
Microcurrent machines shall be operated in such a way that they have a light signal but do not emit current. Neither the physical therapists who place them nor the subjects will be able to distinguish current-emitting machines from placebo machines.
A total of 15 sessions in 7.5 weeks. Twice a week. The session time with placebo will last 60 minutes.
干预措施: Neuromodulation NESA NXSIGNAL® device (Device)
结局指标
主要结局
Pain Pressure Threshold
时间窗: Change from Baseline Pain Pressure Threshold at 1 year
Central sensitization by assessment of the Pressure Pain Threshold (PPU) in kg: Baseline 12-0300 MMT algometer at cervical C5-C6, dorsal D5-D6 and anterior tibial muscle.
次要结局
- Quality of life RELATED TO HEALTH(Change from baseline quality of life related to health at 1 year)
- Quality of sleep(Change from Baseline Quality of Sleep at 1 year)
- cardiac variability(Change from Baseline Cardiac variability at 1 year)
- Cortisol levels(Change from Baseline Cortisol level at 1 year)
- effects on fatigue(Change from Baseline fatigue at 1 year)
研究者
Josue Fernandez Carnero
Physiotherapy for Persistent Function by Superficial Neuromodulation
Universidad Rey Juan Carlos