CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 225 enrolled
Drug / intervention
Intracept Treatment +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01446419
NCT01446419N/ACompleted
CompareCT.gov

A Prospective Randomized, Double-blind, Controlled Investigation Evaluating the Intracept Intraosseous Nerve Ablation System for the Reduction of Pain in Patients With Chronic Axial Low Back Pain

Relievant Medsystems, Inc.·interventional·Posted Oct 5, 2011·Updated Oct 31, 2016

In Brief

A clinical study evaluating Intracept Treatment and Sham Treatment for Low Back Pain. Completed, enrolled 225 participants across 13 sites.

Detailed Summary

To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain. This is a prospective, double-blind, randomized, sham-controlled clinical trial with an optional crossover component.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2011
Enrollment StartOct 1, 2011
Primary CompletionMar 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.7 years ago

Interventions

Intracept Treatmentdevice

Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.

Sham Treatmentdevice

Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.