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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02725723

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Stenosis	Device: Therm-AppTM TH, thermographic camera Drug: epidural injection	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subject after 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	Device: Therm-AppTM TH, thermographic camera Drug: epidural injection

Arm

Intervention/Treatment

Experimental: Subject after 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

Device: Therm-AppTM TH, thermographic camera

Drug: epidural injection

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

michal roll, Chief Executive Officer, Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT02725723

Other Study ID Numbers:

TASMC-16-SB-0650-15-CTIL

First Posted:

Apr 1, 2016

Last Update Posted:

Apr 1, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Spinal Stenosis

Study Results

No Results Posted as of Apr 1, 2016