Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain
About this trial
This is an interventional treatment trial for Post-Amputation Pain focused on measuring electrical stimulation, neurostimulation, neuromodulation, post-amputation pain, phantom limb pain, residual limb pain, neuropathic pain, amputee pain
Eligibility Criteria
Key Inclusion Criteria:
- At least 18 years old
- Traumatic lower extremity amputation(s)
- Healed amputation and healthy residual limb based upon the investigator's evaluation
Key Exclusion Criteria:
- Change of prescribed medications affecting pain within the past 4 weeks
- Compromised immune system based on medical history
- Implanted electronic device
- Bleeding disorder
- History of valvular heart disease
- Confounding central nervous system injuries and disorders
- History of recurrent skin infections
Sites / Locations
- Arizona Pain
- University of California San Diego
- Denver Clinic for Extremities at Risk
- International Spine, Pain and Performance Center
- Holy Cross Hospital
- Northwestern University
- Walter Reed National Military Medical Center
- Premier Pain Centers
- Ainsworth Institute of Pain Management
- Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
SPRINT Group 1
SPRINT Group 2
Subjects in Group 1 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
Subjects in Group 2 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System for a total of 8 weeks. They will receive 4 weeks of stimulation and 4 weeks with no stimulation.