RadiculopathyNCT02196883
Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.
A study testing Transforaminal Epidural Steroid Injection in people with Radiculopathy and Spinal Stenosis, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection. Low back pain has a tremendous impact on the individual and society. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Radiculopathy, Spinal Stenosis, Intervertebral Disc Displacement
- What is being tested?
- Transforaminal Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2015
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of Single level spinal stenosis.
- Single level radiculopathy with MRI findings at a different level than clinical pattern.
- Chronic low back pain with radicular symptoms of > 4 weeks, but < 6 months.
- Failure of conservative therapy to include physical and pharmacotherapy.
- Patient is at least 21 years of age.
- Patient is willing to be blinded to treatment until after the 3-month follow up visit.
- Patient is willing and able to review and sign the study's informed consent form.
Who cannot join
- Patient has a mental or physical condition that would invalidate evaluation results.
- Patient has had prior lumbar surgery at any level.
- Patient is pregnant.
- Patient has systemic infection or infection at the proposed injection site.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical Center
Syracuse, New York, 13210
About this study
Official title: A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms
Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection.
Low back pain has a tremendous impact on the individual and society. It not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs.
Read more
Epidural steroid injections (ESIs) are a common treatment option for many forms of low back pain. They have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. The goal of the injections is reduction of pain, increased quality of life and improved function.
This study is being conducted to determine the outcomes of injections given at the "level of MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.
- Being tested
- Transforaminal Epidural Steroid Injection
- Medical subject headings
- Radiculopathy, Spinal Stenosis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Epidural Steroid InjectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MRI Pathology | Active comparator | Not described Receives: Procedure: Transforaminal Epidural Steroid Injection |
| Physical Exam Pathology | Active comparator | Not described Receives: Procedure: Transforaminal Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Measured: 2 weeks to 6months
Secondary outcomes (2)
Short Form 36 Health Survey
Measured: 2 weeks to 6months
Oswestry Disability Index
Measured: 2 weeks to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
Why it stopped: PI no longer part of practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196883
- Sponsor's protocol ID
- 593154-1
- Status last verified
- Jul 2014
- First submitted
- 18 Jul 2014
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms
- ClinicalTrials.gov ID
- NCT02196883
- Acronym / sponsor ID
- 593154-1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI no longer part of practice
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 22 Jul 2014 (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.
Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection.
Low back pain has a tremendous impact on the individual and society. It not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs.
Epidural steroid injections (ESIs) are a common treatment option for many forms of low back pain. They have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. The goal of the injections is reduction of pain, increased quality of life and improved function.
This study is being conducted to determine the outcomes of injections given at the "level of MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI Pathology | Active comparator | Procedure: Transforaminal Epidural Steroid Injection |
| Physical Exam Pathology | Active comparator | Procedure: Transforaminal Epidural Steroid Injection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Single level spinal stenosis.
- Single level radiculopathy with MRI findings at a different level than clinical pattern.
- Chronic low back pain with radicular symptoms of > 4 weeks, but < 6 months.
- Failure of conservative therapy to include physical and pharmacotherapy.
- Patient is at least 21 years of age.
Key exclusion criteria (4 listed)
- Patient has a mental or physical condition that would invalidate evaluation results.
- Patient has had prior lumbar surgery at any level.
- Patient is pregnant.
- Patient has systemic infection or infection at the proposed injection site.
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 |
|---|---|---|
| Transforaminal Epidural Steroid Injection | Procedure or surgery | MRI Pathology, Physical Exam Pathology |
Primary outcome
Visual Analog Scale
Time frame: 2 weeks to 6months
2 secondary outcomes
Short Form 36 Health Survey
Time frame: 2 weeks to 6months
Oswestry Disability Index
Time frame: 2 weeks to 6months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal Epidural Steroid Injection in people with Radiculopathy and Spinal Stenosis, run by State University of New York - Upstate Medical University at 1 site in United States.
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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Visual Analog Scale (time frame: 2 weeks to 6months). 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 14 Jun 2016.