SPRINT Peripheral Nerve Stimulation for the Treatment of Back Pain

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    230
  • sponsor
    SPR Therapeutics, Inc.
Updated on 20 August 2021
chronic pain
back pain
electrical stimulation
spinal cord
peripheral nerve stimulation
acute pain
low back pain

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)

Details
Condition Low Back Pain, Back Pain, Pain, Chronic Back Pain, Post-Surgical Pain, Pain (Pediatric), Lower Back Pain, lumbago, backpain, backache
Treatment SPRINT Peripheral Nerve Stimulation (PNS) System, Standard interventional management of low back pain
Clinical Study IdentifierNCT04246281
SponsorSPR Therapeutics, Inc.
Last Modified on20 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Chronic low back pain

Exclusion Criteria

Body Mass Index (BMI) > 40
Prior lumbar surgery
Implanted electronic device
Pregnant
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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