Post-Acute COVID-19 Syndrome Clinical Trial
Official title:
Physiotherapy for Persistent Function by Superficial Neuromodulation
| NCT number | NCT05681455 |
| Other study ID # | 22/32 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 15, 2023 |
| Est. completion date | July 30, 2023 |
| Verified date | June 2023 |
| Source | Universidad Rey Juan Carlos |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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. .
| Status | Recruiting |
| Enrollment | 24 |
| Est. completion date | July 30, 2023 |
| Est. primary completion date | June 15, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - Women who have had symptoms of PC for more than one year. - Signs of central sensitization. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Department of Physiotherapy, Occupational Therapy, Rehabilitation and Physical Medicine. Faculty of Health Sciences. Rey Juan Carlos University | Alcorcón | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Rey Juan Carlos |
Spain,
Burgess LC, Venugopalan L, Badger J, Street T, Alon G, Jarvis JC, Wainwright TW, Everington T, Taylor P, Swain ID. Effect of neuromuscular electrical stimulation on the recovery of people with COVID-19 admitted to the intensive care unit: A narrative revi — View Citation
Gaber TAK, Ashish A, Unsworth A. Persistent post-covid symptoms in healthcare workers. Occup Med (Lond). 2021 Jun 16;71(3):144-146. doi: 10.1093/occmed/kqab043. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Pressure Threshold | 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. | Change from Baseline Pain Pressure Threshold at 1 year | |
| Secondary | Quality of life RELATED TO HEALTH | SF-36 questionnaire | Change from baseline quality of life related to health at 1 year | |
| Secondary | Quality of life RELATED TO HEALTH | EuroQool-5-D questionnaire | Change from baseline quality of life related to health at 1 year | |
| Secondary | effects on fatigue | MFIS questionnaire (Modificated Fatigue Impact Scale) | Change from Baseline fatigue at 1 year | |
| Secondary | Quality of sleep | Pittsburg questionnaire | Change from Baseline Quality of Sleep at 1 year | |
| Secondary | cardiac variability | HRV (cardiac variability)" in ms 2. "SDNN (Standard deviation of all R-R intervals)" in ms 3. "rMSSD (Root mean square of the union of adjacent R-R intervals)" in ms | Change from Baseline Cardiac variability at 1 year | |
| Secondary | Cortisol levels | Soma OFCII cube device in nmol/L | Change from Baseline Cortisol level at 1 year |