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NCT04538430

Peripheral Nerve Stimulation for Back

Terminated NA Results posted Last updated 6 December 2022
What this trial tests

NA trial testing SPRINT percutaneous peripheral nerve stimulator placed in Back Pain in 7 participants. Terminated before completion.

Timeline
22 November 2019
Primary endpoint
15 May 2021
9 September 2021

Quick facts

Lead sponsorUniversity of Utah
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment7
Start date22 November 2019
Primary completion15 May 2021
Estimated completion9 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Utah

Who can join

18 and older, any sex, with Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Numeric Rating Scale (NRS) Response From SPRINT Percutaneous Peripheral Nerve Stimulator Primary · 2 months

Assessment of Pain Numeric Rating Scale (0-10) response after placement of SPRINT percutaneous peripheral nerve stimulator for chronic low back pain. 0 being no pain and 10 being the worst pain.

GroupValue95% CI
Axial Low Back Pain3.170 – 10

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Back Pain

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04538430.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing