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Peripheral Nerve Stimulation for Back

NCT04538430 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-12-06

Study results available
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Summary

To assess changes in pain, physical function, health-related quality of life, and cost-effectiveness in patients with low back pain, without symptoms of radiculopathy, that have not responded to conservative or traditional interventional measures and are having a SPRINT percutaneous peripheral nerve stimulator placed as standard of care. Patients will be assessed periodically (by questionnaire) after the placement of the SPRINT, FDA approved 60 day, percutaneous peripheral nerve stimulator, targeting the bilateral medial branches at the suspected level of pain generation. Neither the manufacturer nor the FDA are involved or will have access to data from this study.

Conditions

Interventions

DEVICE

SPRINT percutaneous peripheral nerve stimulator placed

Placement of a SPRINT percutaneous peripheral nerve stimulator targeting the bilateral medial branches at the suspected level of pain generation. This procedure is done as standard of care.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2021-05-15
Completion
2021-09-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538430 on ClinicalTrials.gov