Loading clinical trials...

Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain | Clinical Trials | Clareo Health

TERMINATEDNA

Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain

A Multicenter, Randomized, Sham-Controlled, Double-Blinded Study to Evaluate the Analgesic Efficacy and Safety of Pulsed Radiofrequency Energy (PRFE) in Bunionectomy Surgery for the Treatment of Post-Operative Pain

NCT01694199•Regenesis Biomedical, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

The clinical study's primary objective is to compare the overall analgesic effect of the Provant Therapy System (test device) to an identical sham device (placebo) in subjects experiencing post-operative pain following first metatarsal bunion surgery. The study hypothesis is that, over the first 72 hours (3 days) after the initial test device treatment, subjects treated with an active test device will show a statistically significant difference (reduction) in pain intensity scores when compared with subjects treated with a sham (placebo) device. Treatment with the test device will continue through the 168 hour (7 day) timepoint. Safety will be followed through 28 days.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults aged 18-75 years old
•Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy (no collateral procedures) under regional/local anesthesia and sedation
•Subject meets the criteria for American Society of Anesthesiologists (ASA) Physical Status I or II.
•Subject is willing to be confined at the investigative site for approximately 4 days including the day of surgery.
•Subject is able to communicate meaningfully in English in order to complete study assessments and comply with all trial procedures.
•Willingness to give written informed consent and to comply with all parts of the study protocol.
•Female Subjects of child bearing potential are eligible only if they are not pregnant (negative pregnancy test at screening and before surgery), not lactating, and not planning to become pregnant during the study.
•Female Subjects must be post-menopausal, surgically sterile, abstinent, or practicing, or agree to practice, an effective method of birth control if they are sexually active for the duration of the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).

Exclusion Criteria

•Subject is scheduled to undergo Base wedge osteotomy, and/or Long-Z Hart bunionectomy procedure or any other procedure that does not conform to the surgical protocol.
•Subject has received any investigational drug within 1 month prior to the Screening Visit or is enrolled in another clinical trial.
•Subject has a history of drug abuse within 5 years of the screening visit, including a history of opioid (narcotic) analgesic abuse.
•Subject has a history of any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, endocrine or psychiatric disease or disorder, or any uncontrolled medical illness that in the investigator's judgment places the Subject at unacceptable risk for surgery or receipt of investigational therapy.
•Subject has an ongoing, uncontrolled painful condition that in the opinion of the Investigator might have a confounding influence on the safety or efficacy analysis for this study.
•Subject has received systemic corticosteroid administration within 1 month prior to surgery or is scheduled to receive systemic corticosteroid therapy at any time during the course of the study.
•Subject is unwilling to abstain from alcohol from at least midnight the night before surgery through completion of all In-patient Treatment Period procedures and discharge from the investigative site.
•Subject is unwilling to refrain from smoking during his/her stay at the investigative site.
•Subject is currently receiving treatment, or has received treatment within the last two weeks, with antipsychotic drugs, monoamine oxidase inhibitors, duloxetine, gabapentin, carbamazepine, phenytoin, pregabalin or is receiving treatment with antidepressants that are not on a stable dose (the same dose for \>1 month).
•Subject has a history of malignancy within the past five years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
+15 more criteria

Locations (3)

Lotus Clinical Research

Pasadena, California, United States

Chesapeake Research Group

Pasadena, Maryland, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

November 1, 2012

Completion Date

December 1, 2012

Last Updated

May 2, 2017

Enrollment

139

ACTUAL participants

Conditions

Post-operative Pain

Interventions

Pulsed Radiofrequency Energy (PRFE)

DEVICE

No Pulsed Radiofrequency Energy (PRFE)

DEVICE

Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy

NCT05953766

Post-operative Pain

View study

RECRUITINGPHASE4

Simethicone as Part of ERAS in Bariatric Surgery Patients

NCT06812832

SimethiconeBariatric Surgery+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain

Inclusion Criteria

Exclusion Criteria

Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy

Simethicone as Part of ERAS in Bariatric Surgery Patients

Tapentadol vs Tramadol in Total Knee Arthroplasty

TAP Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following TAH

Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control

Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial