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Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain

NCT01694199 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2017-05-02

Study results available
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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.

Conditions

  • Post-operative Pain

Interventions

DEVICE

Pulsed Radiofrequency Energy (PRFE)

The intervention is pulsed radiofrequencyenergy (PRFE).

DEVICE

No Pulsed Radiofrequency Energy (PRFE)

Sham (placebo) with no therapeutic device activity

Sponsors & Collaborators

  • Regenesis Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Neil K. Singla, MD · Lotus Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694199 on ClinicalTrials.gov