Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections

Phase 2

• Conditions: Spinal Stenosis
• Interventions: Device: Therm-AppTM TH, thermographic camera; Drug: epidural injection

• Registration Number: NCT02725723
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Spinal stenosis is a prevalent diagnosis, which is handled in a heterogeneous manner by clinicians. Moreover, when using steroidal epidural injections, successful treatment is currently defined as the satisfaction of the patient from the treatments, a subjective and non-quantifiable indicator.

In this experiment, the investigators aim to evaluate thermographic images as an objective method for assessing the efficacy of steroidal epidural injections, the most common invasive treatment for pain associated with spinal stenosis

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-31
• Last Update Submitted: 2016-03-31
• Study First Posted: 2016-04-01
• Last Update Posted: 2016-04-01
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Signed a valid, IRB/EC-approved informed consent form
• 18 years of age or older when written informed consent is obtained
• Diagnosis of spinal stenosis by MRI or CT imaging

Exclusion Criteria

• Sensitivity to local anesthetics
• Skin infection at the site of needle insertion
• Had evidence of a peripheral neuropathy
• Had clinical signs of peripheral vascular disease
• Patient is pregnant
• Clinical diagnosis of blood clotting disorder
• Tumor or infection at spine as demonstrate at MRI Unbalanced Cardiac Insufficiency, hypertension & Diabetes cataract Stomach Ulcer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subject after epidural injection	epidural injection	Subjects are patients from the clinic who have been diagnosed with Lumbar spinal stenosis and determined eligible for receiving steroidal epidural injection for pain management
Subject after epidural injection	Therm-AppTM TH, thermographic camera	Subjects are patients from the clinic who have been diagnosed with Lumbar spinal stenosis and determined eligible for receiving steroidal epidural injection for pain management

Primary Outcome Measures

Name	Time	Method
Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region	Baseline and 30 min

Secondary Outcome Measures

Name	Time	Method
Change in Pain Intensity by a 0 - 10 numerical rating scale (NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine".	Baseline, 1 month, 3 months