Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

NCT ID: NCT03484429

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-04-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Peripheral nerve stimulation

Intervention Type: DEVICE

Up to 60 days of peripheral nerve stimulation

Standard Medical Therapy

Intervention Type: OTHER

Medications, physical therapy, or other pain treatments

Group 2

Standard medical therapy only

Group Type: ACTIVE_COMPARATOR

Standard Medical Therapy

Intervention Type: OTHER

Medications, physical therapy, or other pain treatments

Interventions

Peripheral nerve stimulation

Up to 60 days of peripheral nerve stimulation

Intervention Type: DEVICE

Standard Medical Therapy

Medications, physical therapy, or other pain treatments

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise Lester, MD

Role: PRINCIPAL_INVESTIGATOR

Hunter Holmes McGuire VA Medical Center

Locations

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2343

Identifier Type: -

Identifier Source: org_study_id