Lumbar RadiculopathyPhase 4NCT07494136
Dose Dependent Steroid Injections
A Phase 4 study testing Triamcinolone 10 Mg/mL Injectable Suspension, Triamcinolone 40 Mg/mL Injectable Suspension and Triamcinolone 80 Mg/mL Injectable Suspension in people with Lumbar Radiculopathy and Sciatica, run by University of Miami at 1 site in United States.
Trial summary
This study aims to evaluate the efficacy of interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, to evaluate the efficacy of interlaminar steroid injections at improving quality of life and function in lumbar radiculopathy at varying doses, and to evaluate difference in efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Radiculopathy, Sciatica, Back Pain With Radiation
- What is being tested?
- Triamcinolone 10 Mg/mL Injectable Suspension, Triamcinolone 40 Mg/mL Injectable Suspension and Triamcinolone 80 Mg/mL Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults able to consent
- Lumbar radiculopathy with MRI-confirmed pathology
- No history of back surgery
- Use of interlaminar approach lumbar spine injections
- No use of oral pain medication other than Tylenol or Acetaminophen during the 6 weeks after injection
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- History of back surgery
- Use of oral pain meds other than Tylenol or Acetaminophen during the 6 weeks after injection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami
Miami, Florida, 33136
Nareka Trewick, MD, 305-243-6605, nareka.trewick@jhsmiami.org
About this study
Official title: Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy
This study aims to evaluate the efficacy of interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, to evaluate the efficacy of interlaminar steroid injections at improving quality of life and function in lumbar radiculopathy at varying doses, and to evaluate difference in efficacy between triamcinolone and dexamethasone interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, with the overarching hypotheses that there is no difference in reported pain reduction, quality of life, or function among patients receiving low, moderate, or high doses, and no difference in reported pain reduction between triamcinolone and dexamethasone.
- Conditions
- Lumbar Radiculopathy, Sciatica, Back Pain With Radiation
- Being tested
- Triamcinolone 10 Mg/mL Injectable Suspension, Triamcinolone 40 Mg/mL Injectable Suspension, Triamcinolone 80 Mg/mL Injectable Suspension, Dexamethasone 2 MG, Dexamethasone 4mg
- Medical subject headings
- Radiculopathy, Sciatica, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone 10 Mg/mL Injectable SuspensionDrug
Also called Nasacort® AQ, Kenalog
A single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Triamcinolone 40 Mg/mL Injectable SuspensionDrug
Also called Nasacort® AQ, Kenalog
A single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Triamcinolone 80 Mg/mL Injectable SuspensionDrug
Also called Nasacort® AQ, Kenalog
A single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Dexamethasone 2 MGDrug
Also called Decadron
A single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Dexamethasone 4mgDrug
Also called Decadron
A single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
Dexamethasone 8 MGDrug
Also called Decadron
A single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone: 10 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg Receives: Drug: Triamcinolone 10 Mg/mL Injectable Suspension |
| Triamcinolone: 40 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg Receives: Drug: Triamcinolone 40 Mg/mL Injectable Suspension |
| Triamcinolone: 80 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg Receives: Drug: Triamcinolone 80 Mg/mL Injectable Suspension |
| Dexamethasone: 2 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg. Receives: Drug: Dexamethasone 2 MG |
| Dexamethasone: 4 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg. Receives: Drug: Dexamethasone 4mg |
| Dexamethasone: 8 mg Group | Experimental | Participants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg. Receives: Drug: Dexamethasone 8 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Numeric Rating Scale 0-10) (NRS)
Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 verbal rating scale in which participants rate their pain on a continuum from 0 (pain) to 10 (max pain). Higher scores indicate greater pain severity.
Measured: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]
Secondary outcomes (2)
Physical Function Oswestry Disability Index (ODI)
Physical function will be measured using the Oswestry Disability Index (ODI), a validated Physical Function Scale from 0% to 100%. The ODI consists of multiple sections, each scored from 0 to 5, with higher scores indicating greater functional impairment. The total score is summed and divided by 50 when all sections are completed, or by 45 if the optional section is excluded. Final scores are expressed as a percentage ranging from 0% (minimal disability) to 100% (bed-bound), with higher percentages representing more severe disability.
Measured: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)
Quality of Life Short Form 36 (SF-36)
Quality of life will be measured using Quality of Life Measure with domain scores from 0 to 100 with, higher scores indicating better health or fewer limitations in that domain.
Measured: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Sep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyed Mostoufi, University of Miami
- Investigators
- Seyed A mostoufi, MD, Principal investigator, Christine E. Lynn Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494136
- Sponsor's protocol ID
- 20250853
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Dependent Response to Interlaminar Steroid Injections for Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT07494136
- Acronym / sponsor ID
- 20250853
- Conditions
- Lumbar Radiculopathy, Sciatica, Back Pain With Radiation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Mar 2026 (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.
This study aims to evaluate the efficacy of interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, to evaluate the efficacy of interlaminar steroid injections at improving quality of life and function in lumbar radiculopathy at varying doses, and to evaluate difference in efficacy between triamcinolone and dexamethasone interlaminar steroid injections at treating pain in lumbar radiculopathy at varying doses, with the overarching hypotheses that there is no difference in reported pain reduction, quality of life, or function among patients receiving low, moderate, or high doses, and no difference in reported pain reduction between triamcinolone and dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone: 10 mg Group | Experimental | Drug: Triamcinolone 10 Mg/mL Injectable SuspensionParticipants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 10 mg |
| Triamcinolone: 40 mg Group | Experimental | Drug: Triamcinolone 40 Mg/mL Injectable SuspensionParticipants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 40 mg |
| Triamcinolone: 80 mg Group | Experimental | Drug: Triamcinolone 80 Mg/mL Injectable SuspensionParticipants in this arm will receive a single interlaminar lumbar spine steroid injection containing Triamcinolone 80 mg |
| Dexamethasone: 2 mg Group | Experimental | Drug: Dexamethasone 2 MGParticipants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 2 mg. |
| Dexamethasone: 4 mg Group | Experimental | Drug: Dexamethasone 4mgParticipants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 4 mg. |
| Dexamethasone: 8 mg Group | Experimental | Drug: Dexamethasone 8 MGParticipants in this arm will receive a single interlaminar lumbar spine steroid injection containing Dexamethasone 8 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults able to consent
- Lumbar radiculopathy with MRI-confirmed pathology
- No history of back surgery
- Use of interlaminar approach lumbar spine injections
- No use of oral pain medication other than Tylenol or Acetaminophen during the 6 weeks after injection
Key exclusion criteria (5 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- History of back surgery
- Use of oral pain meds other than Tylenol or Acetaminophen during the 6 weeks after injection
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 |
|---|---|---|
| Triamcinolone 10 Mg/mL Injectable SuspensionAlso: Nasacort® AQ, KenalogA single 10 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine. | Drug | Triamcinolone: 10 mg Group |
| Triamcinolone 40 Mg/mL Injectable SuspensionAlso: Nasacort® AQ, KenalogA single 40 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine. | Drug | Triamcinolone: 40 mg Group |
| Triamcinolone 80 Mg/mL Injectable SuspensionAlso: Nasacort® AQ, KenalogA single 80 mg Triamcinolone interlaminar lumbar epidural steroid injection administered in the lumbar spine. | Drug | Triamcinolone: 80 mg Group |
| Dexamethasone 2 MGAlso: DecadronA single 2 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine. | Drug | Dexamethasone: 2 mg Group |
| Dexamethasone 4mgAlso: DecadronA single 4 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine. | Drug | Dexamethasone: 4 mg Group |
| Dexamethasone 8 MGAlso: DecadronA single 8 mg Dexamethasone interlaminar lumbar epidural steroid injection administered in the lumbar spine. | Drug | Dexamethasone: 8 mg Group |
Primary outcome
Pain Intensity (Numeric Rating Scale 0-10) (NRS)
Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]
Pain intensity will be measured using the Numeric Rating Scale (NRS), a validated 0-10 verbal rating scale in which participants rate their pain on a continuum from 0 (pain) to 10 (max pain). Higher scores indicate greater pain severity.
2 secondary outcomes
Physical Function Oswestry Disability Index (ODI)
Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)
Quality of Life Short Form 36 (SF-36)
Time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
Seyed A mostoufi, MD principal investigator
Christine E. Lynn Rehabilitation Center
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 Triamcinolone 10 Mg/mL Injectable Suspension, Triamcinolone 40 Mg/mL Injectable Suspension and Triamcinolone 80 Mg/mL Injectable Suspension in people with Lumbar Radiculopathy and Sciatica, run by University of Miami 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nareka Trewick, MD (305-243-6605, nareka.trewick@jhsmiami.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numeric Rating Scale 0-10) (NRS) (time frame: Baseline (pre-procedure), 2 weeks post-procedure (±1 week), 6 weeks post-procedure (±2 weeks)]). 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 12 Aug 2026.