Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Chronic Pain, Post-Surgical Pain, Psychiatric, Podiatry |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 79 |
| Updated: | 4/17/2018 |
| Start Date: | December 1, 2017 |
| End Date: | March 1, 2019 |
| Contact: | Denise Lester, MD |
| Email: | Denise.Lester@va.gov |
| Phone: | 8046755188 |
Effects of Postoperative Percutaneous Peripheral Nerve Stimulation on Acute and Chronic Amputation Pain
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.
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.
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
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
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
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