N/A
N=33
Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System
Post-Amputation Pain · Phantom Limb Pain · Residual Limb Pain
Bottom Line
View on ClinicalTrials.gov: NCT01996254 ↗Enrolled (actual)
33
Serious AEs
9.1%
Results posted
Mar 2020
Primary outcome: Primary: 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 — 7; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPRINT Peripheral Nerve Stimulation (PNS) System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SPR Therapeutics, Inc.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
7; 2 | — |
| PRIMARY Number of Subjects That Experienced at Least One Study-Related Adverse Event in Treatment and Control Groups |
0; 5; 8 | — |
| SECONDARY 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 |
8; 2 | — |
| SECONDARY Proportion of Subjects That Experienced ≥ 50% Reduction in All Qualifying Areas of Pain at Months 3-12 Post-Start of Treatment |
5; 0; 7; 1; 5; 0 | — |
| SECONDARY Proportion of Subjects That Experienced ≥50% Reduction in Average Pain Interference With Daily Activities |
6; 2; 9; 2; 6; 2 | — |
| SECONDARY 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 |
6; 10; 8; 9; 7; 7 | — |
| SECONDARY Depression at Monthly Intervals After Start of Therapy |
-17.69; -11.76; -50.00; -15.38; -55.00; -10.00 | — |
| SECONDARY Change in Opioid Analgesic Usage From Baseline |
32.68; 47.17; 78.79; 45.28 | — |
| SECONDARY Percent Change in Hours of Daily Prosthetic Usage |
2.49; 4.51; 3.23; 9.14 | — |
| SECONDARY Subject Satisfaction Survey |
3; 3; 3; 3; 3; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01996254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.