Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Pain
  • Amputation
  • Chronic Pain
  • Neuroma
  • Phantom Limb Pain
  • Postoperative Pain
  • Residual Limbs
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 surger...

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

Tracking Information

NCT #
NCT03484429
Collaborators
Not Provided
Investigators
Principal Investigator: Denise Lester, MD Hunter Holmes McGuire VA Medical Center