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Column | Value |
---|---|
Trial registration number | NCT05200858 |
Full text link
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
bijan.najafi@bcm.edu |
Registration date
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
2022-01-21 |
Recruitment status
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Recruiting |
Study design
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Crossover |
Masking
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Blind label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
Study aim
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Long covid |
Inclusion criteria
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
inclusion criteria: previous covid-19 infection persistent symptoms of pain, fatigue, weakness, or poor gait and balance after infection assessed by critical care clinicians on the initial consultation willing to attend clinic for assessments |
Exclusion criteria
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
severe cognitive decline reduces their ability to interact with the tens mobile app major visual or hearing weakness reduces the ability to interact with tens mobile app unable to walk independently for a distance of 10 meter major foot problems such as active lower extremity wounds, major foot deformity (e.g., charcot foot), previous major amputations, and claudication demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices; and any conditions that may interfere with outcomes or increase the risk of the use tens based on the judgement of clinicians |
Number of arms
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Baylor College of Medicine |
Inclusion age min
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
100 |
Countries
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
United States |
Type of patients
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
Severity scale
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
40 |
primary outcome
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Change from baseline in Fatigue at 4 weeks;Change from baseline in pain scores at 4 weeks |
Notes
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
Not reported |
Arms
Last imported at : Jan. 23, 2022, 12:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 454, "treatment_name": "Electrical stimulation", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |