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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Spinal Stenosis

Treatments: Drug: epidural injection; Device: Therm-AppTM TH, thermographic camera

Study type: Interventional

Funder types: Other

Identifiers

NCT02725723

TASMC-16-SB-0650-15-CTIL

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Subject after epidural injection

Experimental group

Description:

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

Treatment:

Device: Therm-AppTM TH, thermographic camera

Drug: epidural injection