Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status: Completed

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

Treatments: Device: Peripheral nerve stimulation; Other: Standard Medical Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03484429

2343

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group 1

Experimental group

Description:

Standard medical therapy and 30 to 60 days of peripheral nerve stimulation starting within 7 days after surgery

Treatment:

Device: Peripheral nerve stimulation

Other: Standard Medical Therapy

Group 2

Active Comparator group

Description:

Standard medical therapy only

Treatment:

Other: Standard Medical Therapy