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Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain

Discogenic Pain Clinical Trial

Official title:
Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial

Clinical Trial Summary

A double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain.

Clinical Trial Description

A randomized, double-blind, placebo-controlled study to determine the efficacy of intradiscal injection of bone marrow concentrate on discogenic low back pain. The treatment will be a single injection of autologous bone marrow concentrate into suspected painful disc(s) based upon either prior discography or combination of imaging and exclusion of other anatomic structural sources of pain. The placebo treatment will be an intramuscular injection of normal saline directly dorsal to the transverse process at each suspected level. Outcomes will be measured using VAS and ODI. The primary outcome will be the percentage of patients in the treatment group vs control group at 6 months post-procedure, categorized as a clinical success defined by at least 50% relief of pain. Secondary outcomes will be comparison of success rates at 3 and 12 months, percentage of patients in the two groups with greater than 30% improvement in ODI at 3, 6 and 12 months, Global perceived index at 3, 6, 12 months. Medication log and adjunctive treatments will be recorded and analyzed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03340818
Study type Interventional
Source APM Spine and Sports Physicians
Contact Sara A Tyszko, PA-C
Phone 757-490-4802
Email styszko@jordan-younginstitute.com
Status Recruiting
Phase N/A
Start date August 1, 2018
Completion date January 2021
View Details
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