Lumbar Spinal StenosisPhase 4NCT03245671
Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis
A Phase 4 study testing Kenalog Injectable Product, Decadron Phosphate, Injectable and Epidural Steroid Injection in people with Lumbar Spinal Stenosis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Kenalog Injectable Product, Decadron Phosphate, Injectable and 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
- Dec 2017to Apr 2019
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking/reading adults age 18-90 years
- Patients with complaints of unilateral radicular lower extremity symptoms
- NRS pain score >= 5
- Pain symptoms for at least 1 month's duration
- Patients deemed appropriate for lumbar transforaminal epidural steroid injections by treating spine specialist
- Targeted injection level for L4 or L5
- MRI of lumbosacral spine that demonstrates and confirms single-level neural compression secondary to unilateral lumbosacral foraminal or subarticular stenosis consistent with clinical history and findings
- Lumbar foraminal stenosis severity of grades 1, 2, and 3
Who cannot join
- Patients with multiple symptomatic levels
- Patients who are deemed not appropriate to undergo lumbar transforaminal epidural steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast, patients with high bleeding tendency, pregnancy)
- Patients involved with litigation or worker's compensation cases
- Patients who are unable to answer the questionnaires and perform follow-up visits
- Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis, greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or peripheral neuropathy) that may confuse clinical picture and impact patients' rating and perception of their low back and radicular symptoms
- Patients with other spinal pathologies confirmed on imaging that may explain patient's pain
- Patients who have additional severe foraminal stenosis inferior to the symptomatic level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will not have those levels injected
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study
Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. By assessing the relative efficacy of transforaminal epidural injections of particulate and nonparticulate steroids, this study attempts to further define the appropriate conservative management of painful unilateral radiculopathies due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months following the injection.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Kenalog Injectable Product, Decadron Phosphate, Injectable, Epidural Steroid 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.
Kenalog Injectable ProductDrug
80 mg of Kenalog will be used.
Decadron Phosphate, InjectableDrug
15 mg of Decadron will be used.
Epidural Steroid InjectionProcedure or surgery
Patient will receive epidural steroid injections of either Kenalog or Decadron.
| Study group | Role | What they receive |
|---|---|---|
| Decadron | Active comparator | Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron. Receives: Drug: Decadron Phosphate, Injectable; Procedure: Epidural Steroid Injection |
| Kenalog | Active comparator | Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog. Receives: Drug: Kenalog Injectable Product; Procedure: Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in function (2 weeks post-injection)
This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Measured: 2 weeks post-injection
Improvement in function (6 weeks post-injection)
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Measured: 6 weeks post-injection
Improvement in function (3 months post-injection)
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Measured: 3 months post-injection
Improvement in function (6 months post-injection)
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Measured: 6 months post-injection
Secondary outcomes (4)
Medication use
The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected.
Measured: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Patient satisfaction with the procedure
Satisfaction will be assessed using the North American Spine Society Outcome Questionnaire. Patients will be asked to pick from 4 multiple choice statements regarding their satisfaction with their procedure.
Measured: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Quality of life
This will be assessed using the Veterans RAND 12-item Health Survey.
Measured: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Side effects
Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected.
Measured: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study startDec 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Why it stopped: Unable to address regulatory concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245671
- Sponsor's protocol ID
- 2016-0615
- Status last verified
- Dec 2017
- First submitted
- 7 Aug 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study
- ClinicalTrials.gov ID
- NCT03245671
- Acronym / sponsor ID
- 2016-0615
- Conditions
- Lumbar Spinal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to address regulatory concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 10 Aug 2017 (actual)
- 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.
Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. By assessing the relative efficacy of transforaminal epidural injections of particulate and nonparticulate steroids, this study attempts to further define the appropriate conservative management of painful unilateral radiculopathies due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months following the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decadron | Active comparator | Drug: Decadron Phosphate, Injectable, Procedure: Epidural Steroid InjectionPatients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron. |
| Kenalog | Active comparator | Drug: Kenalog Injectable Product, Procedure: Epidural Steroid InjectionPatients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- English speaking/reading adults age 18-90 years
- Patients with complaints of unilateral radicular lower extremity symptoms
- NRS pain score >= 5
- Pain symptoms for at least 1 month's duration
- Patients deemed appropriate for lumbar transforaminal epidural steroid injections by treating spine specialist
Key exclusion criteria (8 listed)
- Patients with multiple symptomatic levels
- Patients who are deemed not appropriate to undergo lumbar transforaminal epidural steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast, patients with high bleeding tendency, pregnancy)
- Patients involved with litigation or worker's compensation cases
- Patients who are unable to answer the questionnaires and perform follow-up visits
- Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis, greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or peripheral neuropathy) that may confuse clinical picture and impact patients' rating and perception of their low back and radicular symptoms
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 |
|---|---|---|
| Kenalog Injectable Product80 mg of Kenalog will be used. | Drug | Kenalog |
| Decadron Phosphate, Injectable15 mg of Decadron will be used. | Drug | Decadron |
| Epidural Steroid InjectionPatient will receive epidural steroid injections of either Kenalog or Decadron. | Procedure or surgery | Decadron, Kenalog |
Primary outcome
Improvement in function (2 weeks post-injection)
Time frame: 2 weeks post-injection
This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Improvement in function (6 weeks post-injection)
Time frame: 6 weeks post-injection
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Improvement in function (3 months post-injection)
Time frame: 3 months post-injection
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
Improvement in function (6 months post-injection)
Time frame: 6 months post-injection
This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations).
4 secondary outcomes
Medication use
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Patient satisfaction with the procedure
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Quality of life
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
Side effects
Time frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection
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 6 Dec 2017.
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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 Phase 4 study testing Kenalog Injectable Product, Decadron Phosphate, Injectable and Epidural Steroid Injection in people with Lumbar Spinal Stenosis, run by Hospital for Special Surgery, New York 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 8 inclusion and 8 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 6 Dec 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement in function (2 weeks post-injection) (time frame: 2 weeks post-injection). The study lists 4 primary outcomes in all. 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 6 Dec 2017.