Radicular; Neuropathic, Lumbar, LumbosacralNCT01303354
Lumbar Transforaminal Epidural Dexamethasone
A study testing Lumbar Transforaminal Epidural Steroid Injection in people with Radicular; Neuropathic, Lumbar, Lumbosacral, run by Ahadian, Farshad M., M.D. at 2 sites in United States.
Trial summary
The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radicular; Neuropathic, Lumbar, Lumbosacral
- What is being tested?
- Lumbar 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
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults age 18 years and older, unilateral lumbar radicular pain, baseline distal radicular lower extremity pain VAS score ≥ 5/10, and prior favorable response to TFESI
Who cannot join
- pregnancy, infection, coagulopathy, uncontrolled diabetes mellitus, history of allergy to iodinated contrast medium and interventional therapies for pain within 90 days prior to study enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego - Center for Pain Medicine
La Jolla, California, 92037
San Diego VA Healthcare System
La Jolla, California, 92161
About this study
Official title: Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect.
Read the detailed description
Transforaminal epidural steroid injections (TFESI) have been demonstrated to be an effective treatment for radicular pain. Over the last decade, rare but serious complications have been reported following transforaminal epidural steroid injections (TFESI). Recent research indicates that certain types of corticosteroids containing microscopic particles may be responsible for these adverse events. Dexamethasone (DXM) is a non-particulate cortico-steroid that has not been implicated in these adverse events. However, there is inadequate evidence up to date to support the use of Dexamethasone (DXM) for transforaminal epidural steroid injections (TFESI). This study aims to bridge that gap.
- Being tested
- Lumbar Transforaminal Epidural Steroid Injection
- Keywords
- Epidural, Transforaminal, Steroid Injection, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Transforaminal Epidural Steroid InjectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| DXM 4 mg | Experimental | Dexamethasone 4 mg Receives: Procedure: Lumbar Transforaminal Epidural Steroid Injection |
| DXM 8 mg | Experimental | Dexamethasone 8 mg Receives: Procedure: Lumbar Transforaminal Epidural Steroid Injection |
| DXM 12 mg | Experimental | Dexamethasone 12 mg Receives: Procedure: Lumbar Transforaminal Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
Reduction of pain from baseline at each time point.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Secondary outcomes (4)
Oswestry Disability Index (ODI)- change from baseline
Improvement of disability level from baseline at each time point
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Subject Global Impression of Change (SGIC)
Allows comparison of Subject Global Impression of Change (SGIC) between groups at each time point
Measured: 4 weeks, 8 weeks, 12 weeks
Subject Global Satisfaction Scale (SGSS)
Allows comparison of Subject Global Satisfaction Scale (SGSS) among groups at each time point
Measured: 4 weeks, 8 weeks, 12 weeks post injection
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Subjects were specifically assessed for the following adverse events on day-of and one-week post injection: allergic reaction, neurovascular events, pain on injection, paresthesias during the procedure or dysesthesias post procedure, dural puncture, headache, meningismus, neck pain, arm pain, worsening of back pain, worsening of leg pain, facial flusing, mania, insomnia, agitation, hypertension, hyperglycemia. They were also asked to report any other side-effects or complications.
Measured: Day of and 1 week post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radicular; Neuropathic, Lumbar, LumbosacralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahadian, Farshad M., M.D.
- Collaborators
- San Diego Veterans Healthcare System
- Investigators
- Farshad M Ahadian, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303354
- Sponsor's protocol ID
- UCSD IRB 080582
- Status last verified
- Feb 2011
- First submitted
- 4 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahadian FM, McGreevy K, Schulteis G. Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):572-8. doi: 10.1097/AAP.0b013e318232e843.
PubMed 22005659
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01303354
- Acronym / sponsor ID
- UCSD IRB 080582
- Keywords
- Epidural, Transforaminal, Steroid Injection, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ahadian, Farshad M., M.D.
- Collaborators
- San Diego Veterans Healthcare System
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Feb 2011 (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.
The aim of this study is to assess the effectiveness and safety of dexamethasone for transforaminal epidural steroid injection. A secondary aim of this study is to obtain data on the lowest most effective dose of dexamethasone for this treatment and the effective duration of effect.
Detailed description
Transforaminal epidural steroid injections (TFESI) have been demonstrated to be an effective treatment for radicular pain. Over the last decade, rare but serious complications have been reported following transforaminal epidural steroid injections (TFESI). Recent research indicates that certain types of corticosteroids containing microscopic particles may be responsible for these adverse events. Dexamethasone (DXM) is a non-particulate cortico-steroid that has not been implicated in these adverse events. However, there is inadequate evidence up to date to support the use of Dexamethasone (DXM) for transforaminal epidural steroid injections (TFESI). This study aims to bridge that gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DXM 4 mg | Experimental | Procedure: Lumbar Transforaminal Epidural Steroid InjectionDexamethasone 4 mg |
| DXM 8 mg | Experimental | Procedure: Lumbar Transforaminal Epidural Steroid InjectionDexamethasone 8 mg |
| DXM 12 mg | Experimental | Procedure: Lumbar Transforaminal Epidural Steroid InjectionDexamethasone 12 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults age 18 years and older, unilateral lumbar radicular pain, baseline distal radicular lower extremity pain VAS score ≥ 5/10, and prior favorable response to TFESI
Key exclusion criteria (1 listed)
- pregnancy, infection, coagulopathy, uncontrolled diabetes mellitus, history of allergy to iodinated contrast medium and interventional therapies for pain within 90 days prior to study enrollment
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 |
|---|---|---|
| Lumbar Transforaminal Epidural Steroid Injection | Procedure or surgery | DXM 12 mg, DXM 4 mg, DXM 8 mg |
Primary outcome
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Reduction of pain from baseline at each time point.
4 secondary outcomes
Oswestry Disability Index (ODI)- change from baseline
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection
Subject Global Impression of Change (SGIC)
Time frame: 4 weeks, 8 weeks, 12 weeks
Subject Global Satisfaction Scale (SGSS)
Time frame: 4 weeks, 8 weeks, 12 weeks post injection
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day of and 1 week post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
- Derived from this study: PubMed 22005659Ahadian FM, McGreevy K, Schulteis G. Lumbar transforaminal epidural dexamethasone: a prospective, randomized, double-blind, dose-response trial. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):572-8. doi: 10.1097/AAP.0b013e318232e843.
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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.
Farshad M Ahadian, M.D. principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Transforaminal Epidural Steroid Injection in people with Radicular; Neuropathic, Lumbar, Lumbosacral, run by Ahadian, Farshad M., M.D. at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radicular Pain Visual Analogue Scale (VAS) Score change from baseline (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks post injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01303354, which also lists 1 linked publication.
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 24 Feb 2011.