N/A
N=166
Electrical Stimulation for the Treatment of Back Pain Using Peripheral Nerve Stimulation (PNS)
Back Pain · Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03179202 ↗Enrolled (actual)
166
Serious AEs
4.0%
Results posted
Aug 2022
Primary outcome: Primary: Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity — 58 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPRINT Peripheral Nerve Stimulation (PNS) System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- SPR Therapeutics, Inc.
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity |
58 | — |
| PRIMARY Number of Subjects That Experienced at Least One Study-Related Adverse Event |
49 | — |
| SECONDARY Worst Pain Intensity |
7.7; 4.5 | — |
| SECONDARY Oswestry Disability Index (ODI) |
39.1; 23.6 | — |
| SECONDARY Mean Change in Health-Related Quality of Life |
13.2; 26.6; 12.2; 12.8; 7.2; 18.0 | — |
| SECONDARY Beck Depression Inventory (BDI-II) |
8.9; 5.2 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Survey |
12; 39; 23; 8; 0; 1 | — |
| SECONDARY Pain Interference |
5.7; 2.8 | — |
Summary
The purpose of this study is to evaluate the effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the nerves in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators).
Eligibility Criteria
Key Inclusion Criteria
- At least 21 years of age
- Chronic low back pain
Key Exclusion Criteria
- Infection on or around the low back
- Conditions with increased risk of infection (e.g., valvular heart disease, compromised immune system, history of recurrent skin infections)
- Implanted electronic device
- Body Mass Index (BMI) > 40
- Pregnant
Data sourced from ClinicalTrials.gov (NCT03179202). 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.