Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Last updated: June 30, 2021
Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Acute Pain

Pain

Treatment

N/A

Clinical Study ID

NCT03484429
2343
  • Ages > 18
  • All Genders

Study Summary

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nontraumatic transfemoral (above-the-knee) or transtibial (below-the-knee) amputation
  • Presence of postamputation pain rated at least 4 or more

Exclusion

Exclusion Criteria:

  • Beck Depression Inventory score greater than 20
  • Systemic infection
  • Immunocompromised or taking immunosuppressive medications
  • Implanted electronic device
  • Pregnancy
  • Previous allergy to skin contact materials and/or anesthetic agent
  • Altered mental status
  • Inability to provide informed consent

Study Design

Total Participants: 16
Study Start date:
December 01, 2017
Estimated Completion Date:
April 17, 2021

Study Description

16 patients with new nontraumatic transfemoral or transtibial amputation will be enrolled in the study

Having met inclusion criteria, the patients will be randomized to experimental or control groups

Patients in the experimental group undergo placement of PNS leads within 7 days of amputation surgery

Patients in both groups will be treated with standard pharmacologic and nonpharmacologic pain therapies and evaluated weekly for 8 weeks, then at 3, 6, and 12 months postamputation

Connect with a study center

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia 23249
    United States

    Site Not Available

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