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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02725723
Enrollment
40
Registered
2016-04-01
Start date
2016-03-31
Completion date
Unknown
Last updated
2016-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Stenosis

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

Interventions

DEVICETherm-AppTM TH, thermographic camera

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same regionBaseline and 30 min

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026