Back Pain, Low Back Pain
Conditions
Keywords
Electrical Stimulation, Neuromodulation
Brief summary
The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)
Interventions
The SPRINT System delivers mild electrical stimulation to the nerves in your low back. The SPRINT System includes up to two leads (small wires) that are placed through your skin into your low back. The leads attach to devices worn on your body that deliver stimulation (called Stimulators).
PROCEDUREStandard interventional management of low back pain
Your doctor will determine which procedure or intervention is appropriate for your back pain. You may receive radiofrequency ablation, spinal cord stimulation, surgery, or another procedure or treatment, as appropriate.
Sponsors
SPR Therapeutics, Inc.
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Chronic low back pain Key
Exclusion criteria
* Body Mass Index (BMI) \> 40 * Prior lumbar surgery * Implanted electronic device * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in average pain intensity | Up to 3-months after Start of Therapy (SOT) | Average pain is measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. |
| Study-Related Adverse Events (AEs) | During the Medial Branch Block procedure | Occurrence and type of study-related AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in pain interference | Baseline, 3-months after SOT | Measured using question 9 from the Brief Pain Inventory- Short Form. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week. |
| Reduction in disability | Baseline, 3-months after SOT | Measured using the Oswestry Disability Index (ODI). The ODI asks subjects to rate how their back pain impacts ten components of everyday life. For each section, the answers correlate to a scale which ranges from 0 to 5, where 0 is no disability and 5 is maximum disability. |
| Durability of reductions in pain intensity | Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT | Measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. |
| Reduction in worst pain intensity | Baseline, 3-months after SOT | Measured using question 3 from the Brief Pain Inventory- Short Form (BPI-3). BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. |
| Patient Global Impression of Change | 3-months after SOT | Measured using the Patient Global Impression of Change (PGIC) survey. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline. |
| Change in health-related quality of life | Baseline, 3-months after SOT | Measured using the EQ-5D survey. The EQ-5D is a five-level scale. Each level is coded from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems. The EQ-5D also includes a 0 to 100 scale for health status, where 0 indicates "the worst health you can imagine" and 100 indicates "the best health you can imagine". |
| Change in analgesic medication usage | Baseline, 3-months after SOT | Analgesic medication consumption will be collected. |
Countries
United States
Outcome results
None listed