Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain

NCT01694199 | Terminated Results DMC

• 1 other identifier: RBI.2012.003.P.2
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Pulsed Radiofrequency Energy (PRFE); Pain; Postsurgical; Opioids; Pain relief; Medical device; Endorphins

Outcome Measures

Primary Outcomes (1)

• Overall Analgesic Efficacy (Via SPID 0-72 Hrs)

  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 score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.

  Treatment with the test device twice per day, over 3 days (7 total treatments)

Secondary Outcomes (4)

• TOTPAR-Pain Relief Experienced by Patients T0-72 Hours

  Treatment with the test device twice per day, over 3 days (7 total treatments)

• Opioid Consumption Measured in Morphine Equivalents T0-72 Hours

  Treatment with the test device twice per day, over 3 days (7 total treatments)

• Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent

  After 3 days of treatment (T0-72 hours)

• Time to First Use of Supplemental Analgesic Medication

  Treatment with the test device twice per day, over 3 days (7 total treatments)

Study Arms (2)

Active study device with PRFE

ACTIVE COMPARATOR

This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.

Device: Pulsed Radiofrequency Energy (PRFE)

Sham study device with no PRFE

SHAM COMPARATOR

This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.

Device: No Pulsed Radiofrequency Energy (PRFE)

Interventions

Pulsed Radiofrequency Energy (PRFE) DEVICE

The intervention is pulsed radiofrequencyenergy (PRFE).

Also known as: Provant Therapy System

Active study device with PRFE

No Pulsed Radiofrequency Energy (PRFE) DEVICE

Sham (placebo) with no therapeutic device activity

Also known as: Sham Provant Therapy System

Sham study device with no PRFE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Subject has current evidence of alcohol abuse (regularly drinks more than four units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
• Infection (acute or chronic) involving the first metatarsal (or history of such infection) or any other disease of the foot/ankle that in the opinion of the investigator, places the Subject at increased risk for surgical complications or receipt of the investigational therapy.
• Implanted pacemaker, defibrillator, neurostimulator, bone stimulator, cochlear implant, or other implanted device with metal lead(s).
• Implanted metal in the index foot including planned intra-operative use of metallic screw or fixation device.
• History of malignancy in the treatment area.

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (3)

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Rick Isenberg
• Organization: Regenesis Biomedical, Inc.

isenberg@regenesisbio.com

877-970-4970

Study Officials

• Neil K. Singla, MD

  Lotus Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 2, 2017
• Results First Posted: May 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)