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

This study has been terminated.
(IDMC recommendation)
Sponsor:
Information provided by (Responsible Party):
Regenesis Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT01694199
First received: September 24, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Post-surgical Pain
Bunionectomy Pain Model
Device: Pulsed Radiofrequency Energy (PRFE)
Device: No Pulsed Radiofrequency Energy (PRFE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Further study details as provided by Regenesis Biomedical, Inc.:

Primary Outcome Measures:
  • To compare the overall analgesic efficacy (via SPID 0-72hrs) of the PROVANT® Therapy System to an identical sham device in Subjects experiencing post-bunionectomy surgical pain [ Time Frame: Treatment with the test device twice per day, over 3 days (7 total treatments) ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will assess the Sum of time-weighted Pain Intensity Differences (SPID) from the time of initiation of the first postoperative treatment with the test device (T0) to seventy-two hours thereafter (T72).


Secondary Outcome Measures:
  • TOTPAR-Pain Relief Experienced by Patients T0-72 hours [ Time Frame: Treatment with the test device twice per day, over 3 days (7 total treatments) ] [ Designated as safety issue: No ]
    The total pain relief (TOTPAR) will be measured over 3 days (T0-72 hours)

  • Opioid consumption measured in morphine equivalents T0-72 hours [ Time Frame: Treatment with the test device twice per day, over 3 days (7 total treatments) ] [ Designated as safety issue: No ]
    How much total rescue (supplemental) opioid medicine was required for pain relief, over the first 3 days?

  • Subject global assessment of quality of pain control at 72 hrs [ Time Frame: After 3 days of treatment (T0-72 hours) ] [ Designated as safety issue: No ]
  • Time to first use of supplemental analgesic medication [ Time Frame: Treatment with the test device twice per day, over 3 days (7 total treatments) ] [ Designated as safety issue: No ]
    When was the first dose of rescue (supplemental) opioid medicine required for pain relief, over the first 3 days?


Estimated Enrollment: 314
Study Start Date: September 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active study device with PRFE
This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
Device: Pulsed Radiofrequency Energy (PRFE)
The intervention is pulsed radiofrequencyenergy (PRFE).
Other Name: Provant Therapy System
Sham Comparator: Sham study device with no PRFE
This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
Device: No Pulsed Radiofrequency Energy (PRFE)
Sham (placebo) with no therapeutic device activity
Other Name: Sham Provant Therapy System

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Pre-operative 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).

Pre-Operative 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.
  • 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.
  • Subjects who are taking any dosage strength of daily opioids for more than 30 consecutive days, within the past three months prior to surgery.
  • Subject with fibromyalgia, complex regional pain syndrome or other chronic pain syndromes.
  • Subjects with neuropathic or sensory abnormalities of the lower extremities. Abnormal vibratory sensation and/or Semmes-Weinstein monofilament tests.
  • Subject with BMI > 38.
  • Subject with known hypersensitivity, intolerance or contraindication to acetaminophen, oxycodone, morphine or any agent used in the anesthetic protocol that in the opinion of the Investigator will put the Subject at increased risk.

Post-Operative Exclusion Criteria:

  • The Subject does not report a score of moderate or severe on a 4-point categorical rating scale (with categories of none, mild, moderate, or severe) plus a score of ≥4 on an NPRS 11-point categorical rating scale within 8 hours after the end of surgery. End of surgery is defined as time of last suture.
  • The Subject is not able to answer questions and follow commands.
  • The surgical procedure from incision to closure was longer than 2 hours.
  • The Subject has evidence of respiratory insufficiency, such as a respiratory rate that is less than 8 breaths per minute and arterial oxygen saturation by pulse oximetry of less than 95% with supplemental oxygen.
  • There have been any significant deviations from the surgical or anesthetic protocols that would, in the opinion of the investigator, put the Subject at risk of participation in the trial, confound the analgesic endpoints of the trial or cause concern regarding the Subject's ability to participate in the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694199

Locations
United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Texas
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Regenesis Biomedical, Inc.
Investigators
Principal Investigator: Neil K. Singla, MD Lotus Clinical Research, LLC
  More Information

No publications provided

Responsible Party: Regenesis Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT01694199     History of Changes
Other Study ID Numbers: RBI.2012.003.P.2
Study First Received: September 24, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Regenesis Biomedical, Inc.:
Pulsed Radiofrequency Energy (PRFE)
Pain
Post surgical
Opioids
Pain relief
Medical device
Endorphins

ClinicalTrials.gov processed this record on August 19, 2014