Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Department of Defense Funded Pragmatic Clinical Trial

NCT04713098 | Completed DMC FDA Device

• 1 other identifier: STIMULATION (DoD)
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 6

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, quadruple-masked, placebo/sham-controlled, parallel-arm pragmatic clinical trial to determine the effects of percutaneous PNS on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life.

Conditions

Rotator Cuff Repair; Ankle Arthroplasty or Arthrodesis; Hallux Valgus (Bunion) Resection

Outcome Measures

Primary Outcomes (2)

• Opioid consumption during first postoperative week

  Cumulative opioid dose following recovery room discharge for days 0-7

  Postoperative days 0-7, collected on days 1, 2, 3, 4 and 7 for the previous 24 hours at each time point.

• Average pain during first postoperative week

  Mean value of the "average" pain scores following recovery room discharge measured using the numeric rating scale. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10= worst imaginable pain.

  Postoperative days 0-7, collected on days 1, 2, 3, 4 and 7 for the previous 24 hours at each time point

Secondary Outcomes (7)

• Opioid consumption

  Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1,4 and 12.

• Average pain

  Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1,4 and 12.

• Worst/maximum pain

  Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1, 4 and 12.

• Brief pain Inventory, short form (interference subscale)

  Collected on postoperative days, 0, 3, 7 and 18; as well as Months 1, 4 and 12.

• Defense and Veterans Pain Rating Scale

  Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1, 4 and 12.

Study Arms (2)

Peripheral Nerve Stimulation

EXPERIMENTAL

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: Peripheral Nerve Stimulation

Sham

SHAM COMPARATOR

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

Interventions

Peripheral Nerve Stimulation DEVICE

ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days

Also known as: SPR Therapeutics

Peripheral Nerve Stimulation

Sham DEVICE

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

Also known as: SPR Therapeutics

Sham

Eligibility Criteria

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

You may qualify if:

• years of age or older.
• Undergoing one of the following surgical procedures: rotator cuff repair, ankle arthrodesis or arthroplasty, hallux valgus correction.
• With a planned single-injection peripheral nerve block for postoperative analgesia.

You may not qualify if:

• Chronic analgesic use including opioids (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks).
• Neuro-muscular deficit of the target nerve(s).
• 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.
• Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap.
• History of bleeding disorder.
• Antiplatelet or anticoagulation therapies other than aspirin due to the risk of bleeding with a 20-gauge insertion needle.
• Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
• Incarceration.
• Pregnancy.
• Chronic pain of greater than 3 months of any severity in an anatomic location other than the surgical extremity.
• Anxiety disorder.
• History of substance abuse.
• Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access).

Sponsors & Collaborators

• University of California, San Diego: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (6)

Cedars- Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Ankylosis; Hallux Valgus; Bunion

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired

Study Officials

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: January 26, 2021
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (6)