NCT03484429

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Phantom Limb Pain
• Postoperative Pain
• Neuroma
• Acute Pain
• Chronic Pain
• Residual Limbs
• Amputation

Interventions

Type	Name	Description
DEVICE	Peripheral nerve stimulation	Up to 60 days of peripheral nerve stimulation
OTHER	Standard Medical Therapy	Medications, physical therapy, or other pain treatments

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-04-17
• Completion: 2021-04-17
• First posted: 2018-03-30
• Last updated: 2021-07-21
• Results posted: 2021-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study