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Device

Peripheral Nerve Stimulation for Back Pain

N/A

Waitlist Available

Research Sponsored by SPR Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic low back pain

Must not have

Prior lumbar surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two treatments for back pain, one standard and one involving electrical stimulation.

Who is the study for?

This trial is for individuals with chronic low back pain. Participants should not have a BMI over 40, any previous lumbar surgery, implanted electronic devices, or be pregnant.

What is being tested?

The study compares standard treatments for back pain to the SPRINT Peripheral Nerve Stimulation (PNS) System which delivers electrical stimulation to nerves in the lower back and is FDA-cleared for up to 60 days use.

What are the potential side effects?

Potential side effects of the SPRINT PNS system may include discomfort at the stimulation site, skin irritation, and temporary pain increase. Standard care side effects vary based on specific treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have long-term lower back pain.

Select...

I have had lower back pain for a long time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery on my lower back before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-months after sot, 9-months after sot, 12-months after sot, 18-months after sot, 24 months after sot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in average pain intensity

Study-Related Adverse Events (AEs)

Secondary study objectives

Change in analgesic medication usage

Change in health-related quality of life

Durability of reductions in pain intensity

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Group 1: Peripheral Nerve Stimulation (PNS)Active Control1 Intervention

Subjects in Group 1 will have leads placed in their lower back. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.

Group II: Group 2: Standard Interventional Management (Standard of Care)Active Control1 Intervention

Subjects in Group 2 will receive the standard of care. Group 2 subjects may be able to crossover to receive PNS after 12 months from start of treatment (Visit 16).

0 / 3Eligibility criteria met