Chronic Fatigue Syndrome Trial, Completed NCT05200858 Sponsor: Baylor College of Medicine Condition: Chronic Fatigue Syndrome
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT05200858) enrolled 30 people in total — 15 in an active treatment group and 15 in a placebo (dummy treatment) group. The trial ran in two back-to-back four-week periods: a blinded phase (where participants did not know which group they were in) and an unblinded phase (where they did know). The main thing the trial was measuring was how much pain interfered with daily functioning, using a standard questionnaire called the Brief Pain Inventory, scored from 0 (no interference) to 10 (complete interference). Secondary measures included pain severity, fatigue, and aspects of walking such as step rate and timing. The reported data shows that during the blinded phase, the active group's pain interference score changed by an average of 0.454 points on the 0–10 scale, compared to 0.198 points in the placebo group. For pain severity (also on a 0–10 scale), the reported average change was 1.184 points in the active group and 0.289 points in the placebo group. Regarding fatigue (measured on a 0–100 scale), the reported change was 2.821 points in the active group and 2.231 points in the placebo group. For the walking measures, the reported data shows the active group took about 1.13 seconds per stride compared to 1.16 seconds in the placebo group, walked at 106.42 steps per minute versus 105.90, and spent about 22.84% of each stride with both feet on the ground compared to 22.64% in the placebo group. Results from the unblinded phase were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Chronic Fatigue Syndrome Trial, Completed

NCT05200858
Completed Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have previously had a COVID-19 infection
  • Since having COVID-19, you have ongoing symptoms such as pain, tiredness, weakness, or difficulty walking and keeping your balance that were not there before your infection
  • You are willing and able to come to the clinic in person for check-ups and assessments

Who may not be able to join:

  • You have serious memory or thinking problems that would make it difficult to use a TENS device through a mobile phone app
  • You have significant vision or hearing problems that would make it difficult to use the TENS mobile phone app
  • You are unable to walk on your own for a distance of at least 10 metres (roughly 33 feet)
  • You have serious foot or leg problems, such as open wounds on your lower legs or feet, a major foot deformity (for example, a condition called Charcot Foot), a previous major amputation, or severe leg pain when walking due to poor blood circulation
  • You have a certain type of heart pacemaker, an implanted heart device (such as a defibrillator), or any other implanted electronic device, or you have a condition that a doctor believes could be made worse by using a TENS device (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Completed
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 March 2022
Est. completion
1 October 2023

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean Change in Functional Interference From Pain From Baseline to 4 Weeks (Blinded Phase)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov