N/A
N=30
Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2
Postacute Sequelae of Sars-CoV-2 · Post-Acute COVID-19 Syndrome · Widespread Chronic Pain · Fatigue Syndrome, Chronic · Gait, Unsteady
Bottom Line
View on ClinicalTrials.gov: NCT05200858 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase) — 0.454; 0.198 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TENS - high-dose (Device); TENS - low-dose (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase) |
0.454; 0.198 | — |
| SECONDARY Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase) |
1.184; 0.289 | — |
| SECONDARY Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase) |
2.821; 2.231 | — |
| SECONDARY Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase) |
1.13; 1.16 | — |
| SECONDARY Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase) |
106.42; 105.90 | — |
| SECONDARY Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase) |
22.84; 22.64 | — |
| SECONDARY Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase) |
103.40; 103.40 | — |
| SECONDARY Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase) |
122.57; 122.57 | — |
Summary
The purpose of the pilot study is to examine acceptability and proof of concept effectiveness of a wireless TENS technology to address PASC associated FM. Sample size (n=30) is convenient and designed to explore acceptability and feasibility. Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize TENS low-dose devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 4 weeks. Then, the patients will come back after four weeks (4W). At this 4th week visit, both groups will be unblinded and the IG will keep their high-dose TENS device and the PG group will switch from a low-dose TENS to a high-dose TENS device. Both groups will continue to deliver 3-5 hour of stimulation daily, until their final 8th week follow up visit (8W). The primary outcome will be pain. Secondary outcomes include fatigue, limb strength and perfusion, gait assessment (cadence, stride time, double support), balance, pulse oximetry, and quality of life. The coordinator will utilize a weekly spreadsheet showing utilization (therapy sessions/day, logged in the Quell health Cloud) so compliance can be monitored and those that are not using the device can be encouraged.
Eligibility Criteria
Inclusion Criteria
- Previous COVID-19 infection
- Persistent symptoms of pain, fatigue, weakness, or poor gait and balance that were not present before COVID-19 infection
- Willing to attend clinic for assessments
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05200858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.