Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain
CompletedNot applicableNCT03484429
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain
- Conditions
- Phantom Limb Pain
- Postoperative Pain
- Neuroma
- Acute Pain
- Chronic Pain
- Residual Limbs
- Amputation
- Interventions
- Device: Peripheral nerve stimulation
- Other: Standard Medical Therapy
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Start date
- 2017-12-01
- Primary completion
- 2021-04-17
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03484429