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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02725723
• Other study ID #: TASMC-16-SB-0650-15-CTIL
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: March 21, 2016
• Last updated: March 31, 2016
• Start date: March 2016

Study information

• Verified date: March 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

Device:
• Therm-AppTM TH, thermographic camera

Drug:
• epidural injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region		Baseline and 30 min	No
Secondary	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	No