Postacute Sequelae of Sars-CoV-2NCT05200858
Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2
A study testing TENS - high-dose and TENS - low-dose in people with Postacute Sequelae of Sars-CoV-2 and Post-Acute COVID-19 Syndrome, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postacute Sequelae of Sars-CoV-2, Post-Acute COVID-19 Syndrome, Widespread Chronic Pain
- What is being tested?
- TENS - high-dose and TENS - low-dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electrical Nerve Stimulation For Lower Extremity In Patients With Neurogenic Pain - A Proof Of Concept Randomized Clinical Trial
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.
Read the detailed description
Postacute Sequelae of Sars-CoV-2 (PASC) is an emerging entity that has been clearly recognized by musculoskeletal pain, fatigue, cognitive, and sleep disturbances, among other symptoms, in patients who have recovered from severe Sars-CoV-2 infection. Hospitalized survivors have reported a significant excess burden of many of these symptoms up to 8 months after discharge. Particularly in the lower extremity, musculoskeletal illness has been associated with prolonged immobilization, high-risk comorbidities, and the use of glucocorticoids that is commonly administered to these patients. These manifestations are the cardinal symptoms of fibromyalgia (FM), a condition thought to be caused by hyperactive sensory signaling due to central sensitization as well as deficient endogenous pain inhibition, triggered among others, by viral infections. Consequently, FM sequelae are one of the most common long-term complications seen in PASC. Thus, it is expected to impose a serious burden on different medical specialties in a near future. In a population that has persistent lack of symptom resolution such as FM, adherence to therapy could be challenging. Patients with constant pain, fatigue, and sleep disturbances, are difficult to keep motivated, especially those pain-medication dependents that often present low quality of life. One practical solution to address the symptomatology characteristic of FM is the use of transcutaneous electrical stimulation therapy (TENS). Studies have demonstrated its ability to manage pain and fatigue in patients with peripheral neuropathy and FM, and has shown to effectively improve lower-extremity perfusion and oxygen delivery in patients with ischemic lesions. However, TENS has not yet been explored for PASC. Since this technology is dose-dependent, the investigators propose a practical daily-basis therapy that patients with persistent associated FM due to previous COVID-19 infection could apply at home, thus, addressing PASC without relying only on medication. In this matter, Neurometrix Inc. (Woburn, MA, USA) has created a wireless TENS device (Quell®) to address pain, gait, sleep, and fatigue. This technology is placed in the lower-extremity and works through the stimulation of nerves that carry non-painful sensations (A-beta fibers) by closing a neurological "gate" in the spinal cord, thus, reducing transmission from pain nerves (A-delta and C fibers) to the brain. This device utilizes a wireless technology manageable through a smart phone application (Quell App) that also tracks symptom-status. Moreover, Baylor College of Medicine has created the Post-COVID-19 Clinic (McNair Campus, BCM St Luke's, Houston, TX, USA) supervised by specialists in critical and pulmonary care. This Clinic has a high volume of patients that present with PASC, particularly those with associated FM (i.e., persistent muscle pain, fatigue, weakness, atrophy, sleep problems, and/or anxiety). Therefore, the investigators believe Baylor institution is a suitable place to perform this pilot study.
- Conditions
- Postacute Sequelae of Sars-CoV-2, Post-Acute COVID-19 Syndrome, Widespread Chronic Pain, Fatigue Syndrome, Chronic, Gait, Unsteady
- Being tested
- TENS - high-dose, TENS - low-dose
- Keywords
- Transcutaneous nerve electrical stimulation, Pain, Fatigue
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Chronic Pain, Fatigue Syndrome, Chronic, Gait Disorders, Neurologic, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS - high-doseDevice
Also called functional, commercial
Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day.
TENS - low-doseDevice
Also called placebo, sham
Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group at 4 weeks (blinded phase) | Active comparator | The IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. Receives: Device: TENS - high-dose |
| Placebo Group at 4 weeks (blinded phase) | Placebo comparator | The PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Receives: Device: TENS - low-dose |
| Intervention Group at 8 weeks (unblinded phase) | Active comparator | After 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. Receives: Device: TENS - high-dose |
| Placebo Group at 8 weeks (unblinded phase) | Active comparator | After 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks.
The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. Receives: Device: TENS - high-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase)
Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere.
Measured: baseline to 4 weeks
Secondary outcomes (7)
Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase)
Pain severity will be assessed using the Brief Pain Inventory questionnaire composite score for severity. The maximum score is 10, meaning pain as bad as one can imagine, while the minimum score is zero, meaning no pain.
Measured: Baseline to 4 weeks
Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase)
Functional interference from fatigue will be assessed calculating the Global Fatigue Index (GFI) obtained from a validated questionnaire called Multidimensional Assessment Fatigue, which has a minimum score of 0 (no fatigue) and a maximum sore of 100 (severe fatigue).
Measured: Baseline to 4 weeks
Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase)
Stride time will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.
Measured: at 4 weeks
Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase)
Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.
Measured: at 4 weeks
Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase)
Double Support Phase will be measured with wearable sensors (LEGSys, BioSensics, MA) during a free walking task (single task) using normal pace for 30 ft. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.
Measured: at 4 weeks
Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase)
Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a dual walking task (participants asked to count backwards by two while walking) using normal pace for 30 ft. Cadence is defined as rate of number of steps per minute.
Measured: at 4 weeks
Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase)
Cadence will be measured with wearable sensors (LEGSys, BioSensics, MA) during a fast walking task (participants asked to walk at a slightly faster pace) for 30 ft. Cadence is defined as rate of number of steps per minute.
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Mar 2022
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postacute Sequelae of Sars-CoV-2Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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). Both groups will receive their respective devices at the initial visit (BL) and will be asked to return in 4 weeks for follow-up assessment (4W visit). At this 4 week visit, study participants will be unblinded and the IG will keep their high-dose device, while the PG will switch from low-dose to high-dose TENS device. Study participants will return for a final in-person visit at the 8th week (8W), which will include the assessments described above. Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep the commercial (high-dose TENS) device after completion of the 8-week study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200858
- Sponsor's protocol ID
- H-50753-A
- Status last verified
- Jul 2024
- First submitted
- 28 Dec 2021
- Last updated
- 16 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation For Lower Extremity In Patients With Neurogenic Pain - A Proof Of Concept Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05200858
- Acronym / sponsor ID
- H-50753-A
- Conditions
- Postacute Sequelae of Sars-CoV-2, Post-Acute COVID-19 Syndrome, Widespread Chronic Pain, Fatigue Syndrome, Chronic, Gait, Unsteady
- Keywords
- Transcutaneous nerve electrical stimulation, Pain, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- NeuroMetrix, Inc.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Postacute Sequelae of Sars-CoV-2 (PASC) is an emerging entity that has been clearly recognized by musculoskeletal pain, fatigue, cognitive, and sleep disturbances, among other symptoms, in patients who have recovered from severe Sars-CoV-2 infection. Hospitalized survivors have reported a significant excess burden of many of these symptoms up to 8 months after discharge. Particularly in the lower extremity, musculoskeletal illness has been associated with prolonged immobilization, high-risk comorbidities, and the use of glucocorticoids that is commonly administered to these patients. These manifestations are the cardinal symptoms of fibromyalgia (FM), a condition thought to be caused by hyperactive sensory signaling due to central sensitization as well as deficient endogenous pain inhibition, triggered among others, by viral infections. Consequently, FM sequelae are one of the most common long-term complications seen in PASC. Thus, it is expected to impose a serious burden on different medical specialties in a near future. In a population that has persistent lack of symptom resolution such as FM, adherence to therapy could be challenging. Patients with constant pain, fatigue, and sleep disturbances, are difficult to keep motivated, especially those pain-medication dependents that often present low quality of life. One practical solution to address the symptomatology characteristic of FM is the use of transcutaneous electrical stimulation therapy (TENS). Studies have demonstrated its ability to manage pain and fatigue in patients with peripheral neuropathy and FM, and has shown to effectively improve lower-extremity perfusion and oxygen delivery in patients with ischemic lesions. However, TENS has not yet been explored for PASC. Since this technology is dose-dependent, the investigators propose a practical daily-basis therapy that patients with persistent associated FM due to previous COVID-19 infection could apply at home, thus, addressing PASC without relying only on medication. In this matter, Neurometrix Inc. (Woburn, MA, USA) has created a wireless TENS device (Quell®) to address pain, gait, sleep, and fatigue. This technology is placed in the lower-extremity and works through the stimulation of nerves that carry non-painful sensations (A-beta fibers) by closing a neurological "gate" in the spinal cord, thus, reducing transmission from pain nerves (A-delta and C fibers) to the brain. This device utilizes a wireless technology manageable through a smart phone application (Quell App) that also tracks symptom-status. Moreover, Baylor College of Medicine has created the Post-COVID-19 Clinic (McNair Campus, BCM St Luke's, Houston, TX, USA) supervised by specialists in critical and pulmonary care. This Clinic has a high volume of patients that present with PASC, particularly those with associated FM (i.e., persistent muscle pain, fatigue, weakness, atrophy, sleep problems, and/or anxiety). Therefore, the investigators believe Baylor institution is a suitable place to perform this pilot study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- 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). Both groups will receive their respective devices at the initial visit (BL) and will be asked to return in 4 weeks for follow-up assessment (4W visit). At this 4 week visit, study participants will be unblinded and the IG will keep their high-dose device, while the PG will switch from low-dose to high-dose TENS device. Study participants will return for a final in-person visit at the 8th week (8W), which will include the assessments described above. Throughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep the commercial (high-dose TENS) device after completion of the 8-week study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group at 4 weeks (blinded phase) | Active comparator | Device: TENS - high-doseThe IG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a functional device during a blinded period of 4 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. |
| Placebo Group at 4 weeks (blinded phase) | Placebo comparator | Device: TENS - low-doseThe PG will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy with a placebo device during a blinded period of 4 weeks. The placebo device is identical to the functional device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). |
| Intervention Group at 8 weeks (unblinded phase) | Active comparator | Device: TENS - high-doseAfter 4 weeks, the IG will be unblinded, and will continue to receive high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. |
| Placebo Group at 8 weeks (unblinded phase) | Active comparator | Device: TENS - high-doseAfter 4 weeks, the PG will be unblinded and will switch to a high-dose TENS with a functional device for additional 4 weeks until completing 8 weeks. The functional device elicits 1 hour of TENS per session. Each session lasts 1 hour (100% of dose). To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side in a weekly basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS - high-doseAlso: functional, commercialSubjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day. | Device | Intervention Group at 4 weeks (blinded phase), Intervention Group at 8 weeks (unblinded phase), Placebo Group at 8 weeks (unblinded phase) |
| TENS - low-doseAlso: placebo, shamSubjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day. | Device | Placebo Group at 4 weeks (blinded phase) |
Primary outcome
Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase)
Time frame: baseline to 4 weeks
Pain will be assessed with a validated questionnaire called Brief Pain Inventory interference composite score (BPI-I). The maximum score is 10, meaning pain completely interferes, while the minimum score is zero, meaning pain does not interfere.
7 secondary outcomes
Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase)
Time frame: Baseline to 4 weeks
Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase)
Time frame: Baseline to 4 weeks
Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase)
Time frame: at 4 weeks
Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase)
Time frame: at 4 weeks
Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase)
Time frame: at 4 weeks
Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase)
Time frame: at 4 weeks
Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase)
Time frame: at 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS - high-dose and TENS - low-dose in people with Postacute Sequelae of Sars-CoV-2 and Post-Acute COVID-19 Syndrome, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase) (time frame: baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.