Clinical trial NCT03484429: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb Pain
Postoperative Pain
Neuroma
Acute Pain
Chronic Pain
Residual Limbs
Amputation
Keywords: Neurostimulation
Peripheral nerve stimulation
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
First posted: 2018-03-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Average Phantom Limb Pain (PLP) Score
timeFrame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3.
measure: Average Residual Limb Pain (RLP) Score
timeFrame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
measure: Worst Phantom Limb Pain (PLP) Score
timeFrame: Baseline, Weeks 1-4, 5-8, and Month 3
measure: Worst Residual Limb Pain (RLP) Score
timeFrame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
measure: Best Phantom Limb Pain (PLP) Score
timeFrame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
measure: Best Residual Limb Pain (RLP) Score
timeFrame: Baseline, Weeks 1-4, Weeks 5-8, and Month 3
Secondary outcomes:
measure: Number Taking Opioids
timeFrame: Preop, Hospital Discharge, Weeks 1-4, Weeks 5-8, Week 12
measure: Average Oral Morphine Equivalents (OME)
timeFrame: Preoperative, Hospital discharge, Weeks 1-4, Weeks 5-8, and Week 12
measure: Functional Independence Measure (FIM) Scores
timeFrame: Preoperative, Week 4, and Week 8
measure: Pain Interference
timeFrame: Baseline, Weeks 4, 8, and 12
measure: Patient Global Impression of Change (PGIC)
timeFrame: Weeks 4, 8, and 12
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, Weeks 4, 8, and 12
measure: Pain Disability Index (PDI)
timeFrame: Weeks 4, Week 8, and Week 12
measure: 30-day Readmission Rate
timeFrame: 30 days from hospital discharge
measure: Hospital Length of Stay (LOS)
timeFrame: Number of days from surgery to discharge
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Hunter Holmes McGuire VA Medical Center
name: Denise Lester, MD
role: PRINCIPAL_INVESTIGATOR
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