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Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Multicenter Pilot Study

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ClinicalTrials.gov Identifier: NCT03481725
Recruitment Status : Completed
First Posted : March 29, 2018
Results First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Wake Forest Medical Center
Augusta University
The Cleveland Clinic
Brooke Army Medical Center
United States Naval Medical Center, San Diego
Palo Alto VA
Womack Army Medical Center
SPR Therapeutics
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:

Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery.

The current project is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm clinical pilot study to (1) determine the feasibility and optimize the protocol of a planned definitive clinical trial; and (2) estimate the treatment effect of percutaneous PNS on pain and opioid consumption following moderate-to-severely painful ambulatory surgery compared with usual and customary opioid-based analgesia. This will allow determination of the required sample size for a subsequent definitive multicenter clinical trial. Combined, the pilot study and definitive trial have a strong potential to dramatically reduce or obviate postoperative opioid requirements and their resultant negative effects on both individuals and society; while concurrently improving analgesia, increasing the ability to function in daily life, decreasing the risk of transition from acute to chronic pain, and improving quality of life.


Condition or disease Intervention/treatment Phase
Rotator Cuff Repair Anterior Cruciate Ligament Reconstruction Ankle Arthrodesis or Arthroplasty Hallux Valgus Correction Device: ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) Device: SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Non-Pharmacologic Alternative for the Treatment of Postoperative Pain
Actual Study Start Date : July 14, 2018
Actual Primary Completion Date : September 11, 2020
Actual Study Completion Date : January 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Ultrasound
Drug Information available for: Coal Tar

Arm Intervention/treatment
Experimental: Peripheral Nerve Stimulation
ACTIVE percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electrical current
Device: ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio)
ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days

Sham Comparator: Sham
SHAM percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does NOT generate electrical current
Device: SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio)
SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days




Primary Outcome Measures :
  1. Opioid Consumption During First Postoperative Week [ Time Frame: Postoperative days 0-7 ]
    Cumulative opioid dose from days 0-7, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point measured in morphine equivalents

  2. Average Pain During First Postoperative Week [ Time Frame: Postoperative days 0-7 ]
    Mean value of the "average" pain scores measured using the numeric rating scale, collected on days 0, 1, 2, 3, 4, and 7 for the previous 24 hours at each time point. This is a 0-10 Likert scale measuring pain level with 0 = no pain and 10 = worst imaginable pain


Secondary Outcome Measures :
  1. Opioid Consumption Individual Time Points [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4 ]
    Cumulative opioid dose of previous 24 hours (measured in morphine equivalents)

  2. Brief Pain Inventory, Short Form (Interference Domain) [ Time Frame: Postoperative days 3, and 7; as well as Months 1 and 4 ]
    The Brief Pain Inventory (short form) interference domain is comprised of 7 questions involving physical and emotional functioning using a 0-10 Likert scale [0 = no interference; 10 = complete interference]: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The score is calculated by adding the responses for each individual question resulting in a possible range of 0-70 (higher = worse).

  3. Average Pain at Individual Time Points [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4 ]
    Mean of the "average" pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain

  4. Worst Pain at Individual Time Points [ Time Frame: Postoperative days 1, 2, 3, 4, 7, 11, and 15; as well as Months 1 and 4 ]
    Median of the worst pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain

  5. Least Pain at Individual Time Points [ Time Frame: Postoperative days 3 and 7; as well as Months 1 and 4 ]
    Least pain scores of previous 24 hours measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Participants were asked "what was the lowest pain within the last 24 hours measured using the 0 to 10 scale, with 0 equal to no pain and 10 equal to the worst imaginable pain"?

  6. Current Pain at Individual Time Points [ Time Frame: Postoperative days 3 and 7; as well as Months 1 and 4 ]
    Current pain scores at the time of the data-collection phone call measured on a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain

  7. Defense and Veterans Pain Rating Score [ Time Frame: Postoperative days 3, and 7; as well as Months 1 and 4 ]
    Instrument designed to assess pain level specifically for active duty military and Veteran patient populations. It is a Likert scale from 0 (no pain) to 10 (worst imaginable pain).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. undergoing one of the following surgical procedures: rotator cuff repair, anterior cruciate ligament repair with a patellar autograph, ankle arthrodesis or arthroplasty, hallux valgus correction
  3. with a planned single-injection peripheral nerve block for postoperative analgesia

Exclusion Criteria:

  1. chronic analgesic use including opioids (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
  2. neuro-muscular deficit of the target nerve(s)
  3. compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk
  4. implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
  5. history of bleeding disorder
  6. antiplatelet or anticoagulation therapies other than aspirin due to the risk of bleeding with a 20-gauge insertion needle
  7. allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
  8. incarceration
  9. pregnancy
  10. chronic pain of greater than 3 months of any severity in an anatomic location other than the surgical extremity
  11. anxiety disorder
  12. history of substance abuse
  13. inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481725


Locations
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United States, California
University California San Diego
San Diego, California, United States, 92103
Naval Medical Center San Diego
San Diego, California, United States, 92134
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, North Carolina
Womack Army medical Center
Fort Bragg, North Carolina, United States, 28310
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
University of California, San Diego
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Wake Forest Medical Center
Augusta University
The Cleveland Clinic
Brooke Army Medical Center
United States Naval Medical Center, San Diego
Palo Alto VA
Womack Army Medical Center
SPR Therapeutics
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego
  Study Documents (Full-Text)

Documents provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03481725    
Other Study ID Numbers: Pilot STIMULATION (DoD)
NH170005 ( Other Grant/Funding Number: Department of Defense )
First Posted: March 29, 2018    Key Record Dates
Results First Posted: March 18, 2021
Last Update Posted: March 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Coal Tar
Keratolytic Agents
Dermatologic Agents