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Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

H

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status

Completed

Conditions

Postoperative Pain
Residual Limbs
Chronic Pain
Neuroma
Amputation
Acute Pain
Phantom Limb Pain

Treatments

Device: Peripheral nerve stimulation
Other: Standard Medical Therapy

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Group 1
Experimental group
Description:
Standard medical therapy and 30 to 60 days of peripheral nerve stimulation starting within 7 days after surgery
Treatment:
Device: Peripheral nerve stimulation
Other: Standard Medical Therapy
Group 2
Active Comparator group
Description:
Standard medical therapy only
Treatment:
Other: Standard Medical Therapy

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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