NCT02725723

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

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 21, 2016

Last Update Submit

March 31, 2016

Conditions

Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

Subject after epidural injection

EXPERIMENTAL

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 cameraDrug: epidural injection

Interventions

Therm-AppTM TH, thermographic cameraDEVICE
Subject after epidural injection
epidural injectionDRUG
Subject after epidural injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed a valid, IRB/EC-approved informed consent form
  • years of age or older when written informed consent is obtained
  • Diagnosis of spinal stenosis by MRI or CT imaging

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Executive Officer

Study Record Dates

First Submitted

March 21, 2016

First Posted

April 1, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Last Updated

April 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share