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NCT05348005 · ClinicalTrials.gov registry record · NA
Use of TENS Unit in the Management of Endometriosis Pain
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05348005: Completed NA study, sponsored by Milton S. Hershey Medical Center.
NCT05348005 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05348005, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.
Primary Outcome
Daily pain during endometriosis flares were recorded using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain). Per subject, an average pain score was calculated for the baseline period (no TENS use) and treatment period (TENS use). Change (treatment minus baseline) was estimated within the context of a repeated measures model; change in the positive direction represents worse outcome, change in the negative direction represents improvement.
Interventions
- DEVICE Ovira Transcutaneous Electrical Nerve Stimulation Unit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-07-28 |
| Est. Completion | 2025-07-16 |
| Phase | NA |
What the finished NCT05348005 record still lists
NCT05348005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Ovira Transcutaneous Electrical Nerve Stimulation Unit is the first listed.
NCT05348005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05348005 about?
NCT05348005 is a clinical study titled "Use of TENS Unit in the Management of Endometriosis Pain". The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal...
What is the current status of trial NCT05348005?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2022-07-28. Estimated completion is 2025-07-16.
What interventions are being tested in trial NCT05348005?
The interventions under investigation include: Ovira Transcutaneous Electrical Nerve Stimulation Unit (DEVICE).
Who is sponsoring clinical trial NCT05348005?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05348005's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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