Skip to main content
OpenTrials
Completed

NCT Number: NCT05200858

Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postacute Sequelae of Sars-CoV-2 COVID-19 Chronic Disease Chronic Pain Coronaviridae Infections Coronavirus Infections Disease Attributes Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Gait Disorders, Neurologic Gait, Unsteady Infections Lung Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Nidovirales Infections Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases Widespread Chronic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS - high-dose

Device

Subjects will receive a functional TENS device (delivers 100% of the dose) to wear for 3-5 hours per day.

Other names: functional, commercial

TENS - low-dose

Device

Subjects will receive a placebo TENS device (delivers 10% of the dose) to wear for 3-5 hours per day.

Other names: placebo, sham

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Change in Pain Severity From Baseline to 4 Weeks (Blinded Phase)

    Time frame: Baseline to 4 weeks

    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.

  2. Mean Change in Functional Interference From Fatigue From Baseline to 4 Weeks (Blinded Phase)

    Time frame: Baseline to 4 weeks

    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).

  3. Stride Time at 4 Weeks During a Simple Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    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.

  4. Cadence at 4 Weeks During a Simple Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    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.

  5. Double Support Phase at 4 Weeks During a Simple Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    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.

  6. Cadence at 4 Weeks During a Dual Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    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.

  7. Cadence at 4 Weeks During a Fast Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    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.

Other outcomes

  1. Stride Time at 4 Weeks During a Dual Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    Stride time 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. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.

  2. Stride Time at 4 Weeks During a Fast Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    Stride time 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. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.

  3. Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 4 Weeks (Blinded Phase)

    Time frame: at 4 weeks

    Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).

  4. Frailty at 4 Weeks (Blinded Phase)

    Time frame: up to 4 weeks

    Frailty will be measured with a upper-extremity wearable sensor (Frailty meter, BioSensics, MA) which enables a frailty index score based on a validated algorithm. Patients with frailty index >0.27 is considered are considered as frail. Patients with a frailty index <0.27 are considered as non-frail. The higher the frailty index, the higher the level of frailty. The frailty index ranges from 0-1.

  5. Sural Nerve Conduction Velocity at 4 Weeks (Blinded Phase)

    Time frame: 4 weeks

    Sural nerve conduction will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 20 m/s to a maximum of 60m/s. Measurements will be obtained at 4 weeks and value will be compared between groups.

  6. Ankle Strength at 4 Weeks (Blinded Phase)

    Time frame: up to 4 weeks

    Ankle strength will be assessed with an ankle dynamometer. Participants will be asked to perform 3 maximum voluntary contractions (MVC) sustaining ankle dorsiflexion for 5 seconds with 30 seconds of resting in between MVCs. The average of the 3 MVCs will then be calculated per lower extremity.

  7. Plantar Tissue Oxygen Saturation at 4 Weeks (Blinded Phase)

    Time frame: up to 4 weeks

    Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.

  8. Mean Daily Step Count at 4 Weeks (Blinded Phase)

    Time frame: up to 4 weeks

    Step count obtained with the mean 90 percentile will be will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)

  9. Sleep Duration at 4 Weeks (Blinded Phase)

    Time frame: up to 4 weeks

    Daily sleep duration in hours obtained with the mean 90 percentile will be measured over the course of the 4 weeks using a smart watch (Vivosmart 4, Garmin, US)

  10. Sural Nerve Amplitude at 4 Weeks (Blinded Phase)

    Time frame: at 4 weeks

    Sural nerve amplitude will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 0 microVolts to a maximum of 32 microVolts. Measurements will be obtained at 4 weeks.

  11. Mean Change in Functional Interference From Pain at 8 Weeks (Unblinded Phase)

    Time frame: from week 4 to week 8

    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. This outcome assesses the difference between the mean BPI interference composite score at week 8 and week 4.

  12. Mean Change in Pain Severity From 4 Weeks to 8 Weeks (Unblinded Phase)

    Time frame: 4 weeks to 8 weeks

    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. This outcome assesses the difference between the mean BPI severity composite score at week 8 and week 4.

  13. Mean Change in Functional Interference From Fatigue From 4 Weeks to 8 Weeks (Unblinded Phase)

    Time frame: 4 weeks to 8 weeks

    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). This outcome assesses the difference between the mean global fatigue index at week 8 and week 4.

  14. Stride Time at 8 Weeks During a Simple Walking Task (Unblinded Phase)

    Time frame: at 8 weeks

    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.

  15. Gastrocnemius Muscle Endurance (Muscle Sustained Contraction) in Response to Electrical Stimulation at 8 Weeks (Unblinded Phase)

    Time frame: at 8 weeks

    Gastrocnemius muscle endurance in response to 5 minutes of electrical stimulation therapy will be assessed with surface electromyography using a validated non-invasive device (Delsys Trino Wireless EMG System, MA, US).

  16. Frailty at 8 Weeks (Unblinded Phase)

    Time frame: at 8 weeks

    Frailty will be measured with an upper-extremity wearable sensor (Frailty meter, BioSensics, MA) which enables a frailty index score based on a validated algorithm. Patients with frailty index >0.27 is considered are considered as frail. Patients with a frailty index <0.27 are considered as non-frail. The higher the frailty index, the higher the level of frailty. The frailty index ranges from 0-1.

  17. Sural Nerve Conduction Velocity at 8 Weeks (Unblinded Phase)

    Time frame: at 8 weeks

    Sural nerve conduction will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 20 m/s to a maximum of 60m/s. Measurements will be obtained at 8 weeks and value will be compared between groups.

  18. Ankle Strength at 8 Weeks (Unblinded Phase)

    Time frame: at 8 weeks

    Ankle strength will be assessed with an ankle dynamometer. Participants will be asked to perform 3 maximum voluntary contractions (MVC) sustaining ankle dorsiflexion for 5 seconds with 30 seconds of resting in between MVCs. The average of the 3 MVCs will then be calculated per lower extremity.

  19. Plantar Tissue Oxygen Saturation at 8 Weeks (Unblinded Phase)

    Time frame: at 8 weeks

    Percentage of tissue oxygen saturation (SatO2) will be measured using a validated near-infrared (NIR) camera (Snapshot NIR, KENT Imaging Inc., Calgary, AB, Can) that detects an approximate value of real-time SatO2 level in superficial tissue. The metatarsus area including the five toes will be traced.

  20. Mean Daily Step Count at 8 Weeks (Unblinded Phase)

    Time frame: Starting at 4 weeks up to 8 weeks

    Step count obtained with the mean 90 percentile will be will be measured starting from 4 weeks up to 8 weeks using a smart watch (Vivosmart 4, Garmin, US)

  21. Sleep Duration at 8 Weeks (Unblinded Phase)

    Time frame: Starting at 4 weeks up to 8 weeks

    Daily sleep duration in hours obtained with the mean 90 percentile will be measured starting from 4 weeks up to 8 weeks using a smart watch (Vivosmart 4, Garmin, US)

  22. Sural Nerve Amplitude at 8 Weeks (Unblinded Phase)

    Time frame: up to 8 weeks

    Sural nerve amplitude will be assessed with a DPN Check device (Neurometrix Inc, MA). The device elicits a electrical stimulation upon contact with the skin on the ankle area and returns values that can range from a minimum of 0 microVolts to a maximum of 32 microVolts. Measurements will be obtained at 8 weeks.

  23. Double Support Phase at 4 Weeks During a Dual Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    Double Support Phase 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. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.

  24. Double Support Phase at 4 Weeks During a Fast Walking Task (Blinded Phase)

    Time frame: at 4 weeks

    Double Support Phase 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. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.

  25. Double Support Phase at 8 Weeks During a Simple Walking Task (Unblinded Phase)

    Time frame: at 8 weeks

    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.

  26. Double Support Phase at 8 Weeks During a Dual Task (Unblinded Phase)

    Time frame: at 8 weeks

    Double Support Phase 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. Double support phase is defined as percentage time when both feet are simultaneously in contact with the ground during a single stride.

  27. Stride Time at 8 Weeks During a Dual Task (Unblinded Phase)

    Time frame: at 8 weeks

    Stride time 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. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.

  28. Stride Time at 8 Weeks During a Fast Walk Task (Unblinded Phase)

    Time frame: at 8 weeks

    Stride time 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. Stride time is defined as the period elapsed between the first contact of two consecutive footsteps of the same foot expressed in seconds.

  29. Cadence at 8 Weeks During a Simple Walking Task (Unblinded Phase)

    Time frame: at 8 weeks

    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.

  30. Cadence at 8 Weeks During a Dual Task (Unblinded Phase)

    Time frame: at 8 weeks

    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.

  31. Cadence at 8 Weeks During a Fast Walking Task (Unblinded Phase)

    Time frame: at 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • NeuroMetrix, Inc.

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation For Lower Extremity In Patients With Neurogenic Pain - A Proof Of Concept Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 21, 2022
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.