Spinal StenosisPhase 2/3NCT02725723
Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections
A Phase 2/3 study testing Therm-AppTM TH, thermographic camera and epidural injection in people with Spinal Stenosis, run by Tel-Aviv Sourasky Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Therm-AppTM TH, thermographic camera and epidural injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Conditions
- Spinal Stenosis
- Being tested
- Therm-AppTM TH, thermographic camera, epidural injection
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therm-AppTM TH, thermographic cameraDevice
epidural injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Therm-AppTM TH, thermographic camera; Drug: epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ts (Skin Temperature) will be determined at image taken by Therm-AppTM TH camera at the same region
Measured: 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".
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725723
- Sponsor's protocol ID
- TASMC-16-SB-0650-15-CTIL
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermographic Images as an Objective Method for Assessing the Efficacy of Steroidal Epidural Injections
- ClinicalTrials.gov ID
- NCT02725723
- Acronym / sponsor ID
- TASMC-16-SB-0650-15-CTIL
- Conditions
- Spinal Stenosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject after epidural injection | Experimental | Device: Therm-AppTM TH, thermographic camera, Drug: epidural injectionSubjects are patients from the clinic who have been diagnosed with Lumbar spinal stenosis and determined eligible for receiving steroidal epidural injection for pain management |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therm-AppTM TH, thermographic camera | Device | Subject after epidural injection |
| epidural injection | Drug | Subject after epidural injection |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Therm-AppTM TH, thermographic camera and epidural injection in people with Spinal Stenosis, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.