Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Completed · Not applicable

Conditions studied: Phantom Limb Pain, Postoperative Pain, Neuroma, Acute Pain, Chronic Pain, Residual Limbs, Amputation

In brief

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.

Key facts

Study ID

NCT03484429

Run by

Hunter Holmes Mcguire Veteran Affairs Medical Center

People needed

16

Starts

2017-12-01

Expected to finish

2021-04-17

Last updated by the study team

2021-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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