--- title: Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain nct_id: NCT03484429 overall_status: COMPLETED phase: NA sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center study_type: INTERVENTIONAL primary_condition: Phantom Limb Pain countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03484429.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03484429" ct_last_update_post_date: 2021-07-21 last_seen_at: "2026-05-12T07:10:13.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain **Official Title:** Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain **NCT ID:** [NCT03484429](https://clinicaltrials.gov/study/NCT03484429) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 16 - **Lead Sponsor:** Hunter Holmes Mcguire Veteran Affairs Medical Center - **Conditions:** Phantom Limb Pain, Postoperative Pain, Neuroma, Acute Pain, Chronic Pain, Residual Limbs, Amputation - **Start Date:** 2017-12-01 - **Completion Date:** 2021-04-17 - **CT.gov Last Update:** 2021-07-21 ## 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 ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Group 1** (EXPERIMENTAL) — Standard medical therapy and 30 to 60 days of peripheral nerve stimulation starting within 7 days after surgery - **Group 2** (ACTIVE_COMPARATOR) — Standard medical therapy only ## Interventions - **Peripheral nerve stimulation** (DEVICE) — Up to 60 days of peripheral nerve stimulation - **Standard Medical Therapy** (OTHER) — Medications, physical therapy, or other pain treatments ## Primary Outcomes - **Average Phantom Limb Pain (PLP) Score** _(time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.)_ — Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points. - **Average Residual Limb Pain (RLP) Score** _(time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3)_ — Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their RLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points. - **Worst Phantom Limb Pain (PLP) Score** _(time frame: Baseline, Weeks 1-4, 5-8, and Month 3)_ — Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points. - **Worst Residual Limb Pain (RLP) Score** _(time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3)_ — Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their RLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points. - **Best Phantom Limb Pain (PLP) Score** _(time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3)_ — Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points. - **Best Residual Limb Pain (RLP) Score** _(time frame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3)_ — Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their RLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points. ## Secondary Outcomes - **Number Taking Opioids** _(time frame: Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12)_ - **Average Oral Morphine Equivalents (OME)** _(time frame: Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12)_ - **Functional Independence Measure (FIM) Scores** _(time frame: Preoperative, Week 4, and Week 8)_ - **Pain Interference** _(time frame: Baseline, Weeks 4, 8, and 12)_ - **Patient Global Impression of Change (PGIC)** _(time frame: Weeks 4, 8, and 12)_ - **Pain Catastrophizing Scale (PCS)** _(time frame: Baseline, Weeks 4, 8, and 12)_ - **Pain Disability Index (PDI)** _(time frame: Weeks 4, Week 8, and Week 12)_ - **30-day Readmission Rate** _(time frame: 30 days from hospital discharge)_ - **Hospital Length of Stay (LOS)** _(time frame: Number of days from surgery to discharge)_ ## Locations (1) - Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.hunter holmes mcguire va medical center|richmond|virginia|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03484429.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03484429* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*