Clinical trial NCT01996254: Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Pilot Study of the SPRINT Peripheral Nerve Stimulation (PNS) System for the Treatment of Post-Amputation Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Amputation Pain
Phantom Limb Pain
Residual Limb Pain
Keywords: electrical stimulation
neurostimulation
neuromodulation
post-amputation pain
phantom limb pain
residual limb pain
neuropathic pain
amputee pain
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: NDI Medical, LLC
name: United States Department of Defense
First posted: 2013-11-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).


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

Primary outcomes:
measure: Proportion of Group 1 (Treatment) and Group 2 (Control) Subjects That Achieved ≥ 50% Reduction in All Qualifying Areas of Pain in the First 4 Weeks of Treatment
timeFrame: Baseline and Weeks 1-4 Post-Start of Treatment
measure: Number of Subjects That Experienced at Least One Study-Related Adverse Event in Treatment and Control Groups
timeFrame: Each participant enrolled was assessed for adverse events from the time of informed consent through the 12-month follow up visit. The total assessment period was approximately 13 months for each participant.
Secondary outcomes:
measure: Number of Group 1 (Treatment) Subjects That Experienced ≥ 50% Reduction in All Qualifying Areas of Pain During Weeks 5-8 Compared to Group 2 (Control) Subjects During Weeks 1-4
timeFrame: Baseline and Weeks 1-8 Post-Start of Treatment
measure: Proportion of Subjects That Experienced ≥ 50% Reduction in All Qualifying Areas of Pain at Months 3-12 Post-Start of Treatment
timeFrame: 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-months Post-SOT, and 12-months Post-SOT
measure: Proportion of Subjects That Experienced ≥50% Reduction in Average Pain Interference With Daily Activities
timeFrame: Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT
measure: Proportion of Group 1 (Treatment) Subjects That Experienced ≥ 10-point Reduction in Pain Disability at Monthly Intervals Post-Start of Treatment Compared to Group 2 (Control) Subjects at Week 4 Post-Start of Treatment
timeFrame: Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT
measure: Depression at Monthly Intervals After Start of Therapy
timeFrame: Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT
measure: Change in Opioid Analgesic Usage From Baseline
timeFrame: Baseline, 4-weeks Post-Start of Treatment (SOT), and 8-weeks Post-SOT
measure: Percent Change in Hours of Daily Prosthetic Usage
timeFrame: Baseline, 4-weeks Post-Start of Treatment (SOT), and 8-weeks Post-SOT
measure: Subject Satisfaction Survey
timeFrame: Visit 11 (8-weeks post-Start of Treatment (SOT))
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Pain
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Denver
country: United States
facility: Denver Clinic for Extremities at Risk
state: Colorado
city: Washington
country: United States
facility: International Spine, Pain and Performance Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Shrewsbury
country: United States
facility: Premier Pain Centers
state: New Jersey
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
Study officials:
affiliation: SPR Therapeutics, Inc.
name: Josh Boggs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilmore CA, Ilfeld BM, Rosenow JM, Li S, Desai MJ, Hunter CW, Rauck RL, Nader A, Mak J, Cohen SP, Crosby ND, Boggs JW. Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2019 Nov 17:rapm-2019-100937. doi: 10.1136/rapm-2019-100937. Online ahead of print.
citation: Gilmore C, Ilfeld B, Rosenow J, Li S, Desai M, Hunter C, Rauck R, Kapural L, Nader A, Mak J, Cohen S, Crosby N, Boggs J. Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial. Reg Anesth Pain Med. 2019 Jun;44(6):637-645. doi: 10.1136/rapm-2018-100109. Epub 2019 Apr 5.