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

Primary Purpose

Spinal Stenosis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Therm-AppTM TH, thermographic camera
epidural injection
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Stenosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Subject after epidural injection

    Arm 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

    Outcomes

    Primary Outcome Measures

    Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region

    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".

    Full Information

    First Posted
    March 21, 2016
    Last Updated
    March 31, 2016
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02725723
    Brief Title
    Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections
    Official Title
    Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Stenosis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Subject after epidural injection
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Device
    Intervention Name(s)
    Therm-AppTM TH, thermographic camera
    Intervention Type
    Drug
    Intervention Name(s)
    epidural injection
    Primary Outcome Measure Information:
    Title
    Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region
    Time Frame
    Baseline and 30 min
    Secondary Outcome Measure Information:
    Title
    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".
    Time Frame
    Baseline, 1 month, 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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