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NCT01694199 · ClinicalTrials.gov registry record · NA
Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain
A NA study, sponsored by Regenesis Biomedical.
- Terminated
- Registry status
- NA
- Development phase
- 139
- Enrollment target
NCT01694199: Clinical Trial NA study, sponsored by Regenesis Biomedical.
NCT01694199 is a NA study that was terminated before completion, run by Regenesis Biomedical. The registered enrollment target is 139 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01694199, a NA study, was terminated before completion, sponsored by Regenesis Biomedical.
- TERMINATED
- Registry status
- NA
- Development phase
- 139 participants
- Enrollment target
Study Summary
Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.
Primary Outcome
Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total
Interventions
- DEVICE Pulsed Radiofrequency Energy (PRFE)
- DEVICE No Pulsed Radiofrequency Energy (PRFE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2012-09 |
| Est. Completion | 2012-12 |
| Phase | NA |
Why NCT01694199 stopped before completion
NCT01694199 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Pulsed Radiofrequency Energy (PRFE) is the first listed.
NCT01694199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01694199 about?
NCT01694199 is a clinical study titled "Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain". Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.
What is the current status of trial NCT01694199?
This trial is currently terminated. It is a NA study. The enrollment target is 139 participants. The study started on 2012-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01694199?
The interventions under investigation include: Pulsed Radiofrequency Energy (PRFE) (DEVICE), No Pulsed Radiofrequency Energy (PRFE) (DEVICE).
Who is sponsoring clinical trial NCT01694199?
This trial is sponsored by Regenesis Biomedical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01694199's enrollment target sits among peer trials
139 720th of 2000 higher than 1,281 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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