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Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device

Chronic Pain Clinical Trial

Official title:
A Single Arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device

Clinical Trial Summary

The PainTEQ study is a prospective, multi-site, prospective, single arm study intended to collect clinical data outcomes data associated with the treatment of sacroiliac disease with the LinQ fusion procedure. Data will be collected using self-report measures including the visual analog scale (VAS) for pain assessment where the participant is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Other self-report questionnaires will be administered including the Oswestry Disablity Index (ODI) to measure low-back pain and disability, and the Patient-Reported Outcomes Measurement Information System 29 (PROMIS 29) to measure physical, mental, and social health and well-being.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04423120
Study type Observational
Source PainTEQ, LLC
Contact
Status Completed
Phase
Start date March 13, 2020
Completion date April 30, 2023
View Details
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