N/A
N=16
Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain
Phantom Limb Pain · Postoperative Pain · Neuroma · Acute Pain · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03484429 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Average Phantom Limb Pain (PLP) Score — 4.1; 3.1; 2.2; 3.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peripheral nerve stimulation (Device); Standard Medical Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Phantom Limb Pain (PLP) Score |
4.1; 3.1; 2.2; 3.0; 1.0; 2.2 | — |
| PRIMARY Average Residual Limb Pain (RLP) Score |
7.1; 4.4; 3.6; 2.2; 1; 2.1 | — |
| PRIMARY Worst Phantom Limb Pain (PLP) Score |
6.5; 5.9; 3.1; 5.4; 2.2; 3.6 | — |
| PRIMARY Worst Residual Limb Pain (RLP) Score |
8.3; 7.8; 5.1; 4.1; 1.7; 3.2 | — |
| PRIMARY Best Phantom Limb Pain (PLP) Score |
1.4; 1.3; 0.8; 1.4; 0.6; 1.1 | — |
| PRIMARY Best Residual Limb Pain (RLP) Score |
4.1; 1.5; 1.7; 1.0; 0.4; 1.0 | — |
| SECONDARY Number Taking Opioids |
3; 2; 6; 7; 3; 5 | — |
| SECONDARY Average Oral Morphine Equivalents (OME) |
36.1; 7.2; 44.1; 36.1; 23.4; 16.6 | — |
| SECONDARY Functional Independence Measure (FIM) Scores |
1; 1; 1; 1.2; 1.7; 1.3 | — |
| SECONDARY Pain Interference |
2.7; 3.7; 2; 1.1; 1.0; 1.0 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
4.3; 3.9; 4.1; 5.1; 3.8; 2.4 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
20.3; 12.3; 10.3; 8; 4.1; 4.6 | — |
| SECONDARY Pain Disability Index (PDI) |
22.2; 6; 15.9; 6; 44.7; 7.7 | — |
| SECONDARY 30-day Readmission Rate |
0; 2 | — |
| SECONDARY Hospital Length of Stay (LOS) |
7; 6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03484429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.