Lumbar Spine Disc HerniationNCT01397552
Dexamethasone Versus Depo Medrol in Lumbar Epidurals
A study testing Dexamethasone and methylprednisolone acetate in people with Lumbar Spine Disc Herniation and Lumbar Radiculitis, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will be conducted on subjects that have not had previous injections or have not had an injection in the last 12 months. Subjects must be receiving one level injection and not had prior surgery at that level. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Lumbar Spine Disc Herniation, Lumbar Radiculitis, Lumbar Back Pain
- What is being tested?
- Dexamethasone and methylprednisolone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic low back pain of radicular origin of > 4 weeks but < 6 months
- Failure of conservative therapy to include physical therapy and pharmacotherapy
- Patient is at least 21 years of age
- Patient is willing to be blinded to treatment until after the 12 week post injection visit.
- Patient is willing and able to review and sign the study 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 scheduled to have more than one level of steroid injection.
- Patient is pregnant
- Patient has systemic infection at the proposed injection site
- Patient has osteopenia osteoporosis, or osteomalacia
Show all 14Show fewer
- Patient has a disease of bone metabolism
- Patient has history of renal insufficiency or kidney disease of any kind
- Patient is undergoing chemotherapy or radiation treatment
- Patient is currently involved in a study of another product for similar purpose
- Patient requires post op management with NSAIDS
- Patient has know allergy to corticosteroids, contrast dye or anesthetics
- Patient is unable to speak/read English
- Patient is a prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections
Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will be conducted on subjects that have not had previous injections or have not had an injection in the last 12 months. Subjects must be receiving one level injection and not had prior surgery at that level.
Read the detailed description
Central Epidural Steroid Injections (ESI) and Selective Nerve Root Blocks (SNRB) are often used for the non-surgical treatment of lumbar disc herniations and lumbar radiculitis (radiating pain). Numerous authors have reported on their value in treating patients with radicular pain with the possibility of delaying or even obviating the need for surgery in well-selected patients.. There are two well-performed clinical studies in the peer-reviewed medical literature that specifically examined the crossover rates to surgery for patients who received either ESI or SNRB. In a prospective study, Buttermann et al. found a crossover rate to surgery for patients with symptomatic disc herniations treated with ESI of 54% (27/50) . In a separate prospective study, Riew et al. followed patients after selective nerve root blocks and found that similarly 53% (29/55) of their patients had avoided surgery after a selective nerve root block during their initial follow-up of 13-28 months. In a later study that followed that same population, 76% (16/21) of those patients who had avoided surgery at one year still avoided surgery at a minimum of five year follow-up.
Epidural steroid injections are a common treatment option for patients with disc herniations and radiating leg pain. They have been used for low back problems since 1922 and are still an integral part of the non-surgical management of a variety of spine related problems. The goal of the injection is reduction in pain, increased quality of life and increased function.
Most practitioners will agree that, while the effects of the injection tend to be temporary-providing relief from pain for one week up to one year-an epidural can be very beneficial for a patient during an acute episode of back and/or leg pain. Importantly, an injection can provide sufficient pain relief to allow a patient to progress with a rehabilitative stretching and exercise program.
Many previous studies on epidural injections did not include use of fluoroscopy or xray to verify proper placement of the medication despite the fact that fluoroscopic guidance is routinely used today. Additionally, many studies do not classify patients according to diagnosis and tend to "lump" different types, sources of pain together.
Commonly used steroid preparations include betamethasone, triamcinolone, dexamethasone and methylprednisolone. Unfortunately, there is no consensus regarding the most effective medication, dose, volume or frequency used for ESIs.
This investigator-initiated study is being conducted to compare the effects of epidural injections on low back pain when using either dexamethasone or methylprednisolone (Depo-Medrol). The physicians listed would like to compare these two medications to assess if one is more effective than the other. Both medications are FDA approved and are not experimental.
Dexamethasone is the only nonparticulate corticosteroid, has a rapid onset that acts as an anti-inflammatory and immunosuppressant.
Depo-Medrol is a synthetic steroid (cortisone) medication which also acts as an anti-inflammatory when physicians administer an epidural for relief of low back pain.
- Being tested
- Dexamethasone, methylprednisolone acetate
- Medical subject headings
- Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called dexpak
10 mg/mL injected into lumbar spine, one level, one injection
methylprednisolone acetateDrug
Also called Depo-Medrol
80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Subjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded Receives: Drug: Dexamethasone |
| methylprednisolone acetate | Active comparator | Subjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded Receives: Drug: methylprednisolone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine if One Medication is Better at Relieving Pain Than the Other.
Subjects will be asked to return at 2 wks, 6 wks and 12 weeks the above time points to complete outcome measurements questionnaires and undergo a neurological examination, the 12 weeks outcome should show improvement s/p injection
Measured: 12 wk post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Low enrollment, too many subjects getting second injection
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Spine Disc HerniationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Lavelle, State University of New York - Upstate Medical University
- Investigators
- Suehun Ho, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397552
- Sponsor's protocol ID
- IRB 5824
- Status last verified
- Oct 2018
- First submitted
- 15 Jul 2011
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind Study to Compare the Effects of Dexamethasone Versus Depo-Medrol When Used in Lumbar Epidural Injections
- ClinicalTrials.gov ID
- NCT01397552
- Acronym / sponsor ID
- IRB 5824
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment, too many subjects getting second injection
- Enrolment
- 8 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 4 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Dexamethasone versus Depo Medrol when used in lumbar epidural injections will be conducted on subjects that have not had previous injections or have not had an injection in the last 12 months. Subjects must be receiving one level injection and not had prior surgery at that level.
Detailed description
Central Epidural Steroid Injections (ESI) and Selective Nerve Root Blocks (SNRB) are often used for the non-surgical treatment of lumbar disc herniations and lumbar radiculitis (radiating pain). Numerous authors have reported on their value in treating patients with radicular pain with the possibility of delaying or even obviating the need for surgery in well-selected patients.. There are two well-performed clinical studies in the peer-reviewed medical literature that specifically examined the crossover rates to surgery for patients who received either ESI or SNRB. In a prospective study, Buttermann et al. found a crossover rate to surgery for patients with symptomatic disc herniations treated with ESI of 54% (27/50) . In a separate prospective study, Riew et al. followed patients after selective nerve root blocks and found that similarly 53% (29/55) of their patients had avoided surgery after a selective nerve root block during their initial follow-up of 13-28 months. In a later study that followed that same population, 76% (16/21) of those patients who had avoided surgery at one year still avoided surgery at a minimum of five year follow-up.
Epidural steroid injections are a common treatment option for patients with disc herniations and radiating leg pain. They have been used for low back problems since 1922 and are still an integral part of the non-surgical management of a variety of spine related problems. The goal of the injection is reduction in pain, increased quality of life and increased function.
Most practitioners will agree that, while the effects of the injection tend to be temporary-providing relief from pain for one week up to one year-an epidural can be very beneficial for a patient during an acute episode of back and/or leg pain. Importantly, an injection can provide sufficient pain relief to allow a patient to progress with a rehabilitative stretching and exercise program.
Many previous studies on epidural injections did not include use of fluoroscopy or xray to verify proper placement of the medication despite the fact that fluoroscopic guidance is routinely used today. Additionally, many studies do not classify patients according to diagnosis and tend to "lump" different types, sources of pain together.
Commonly used steroid preparations include betamethasone, triamcinolone, dexamethasone and methylprednisolone. Unfortunately, there is no consensus regarding the most effective medication, dose, volume or frequency used for ESIs.
This investigator-initiated study is being conducted to compare the effects of epidural injections on low back pain when using either dexamethasone or methylprednisolone (Depo-Medrol). The physicians listed would like to compare these two medications to assess if one is more effective than the other. Both medications are FDA approved and are not experimental.
Dexamethasone is the only nonparticulate corticosteroid, has a rapid onset that acts as an anti-inflammatory and immunosuppressant.
Depo-Medrol is a synthetic steroid (cortisone) medication which also acts as an anti-inflammatory when physicians administer an epidural for relief of low back pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneSubjects randomized to receive dexamethasone, will undergo epidural using this medication, however the physician and subject will be blinded |
| methylprednisolone acetate | Active comparator | Drug: methylprednisolone acetateSubjects randomized to receive methylprednisolone acetate, will undergo epidural using this medication, however the physician and subject will be blinded |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic low back pain of radicular origin of > 4 weeks but < 6 months
- Failure of conservative therapy to include physical therapy and pharmacotherapy
- Patient is at least 21 years of age
- Patient is willing to be blinded to treatment until after the 12 week post injection visit.
- Patient is willing and able to review and sign the study informed consent form.
Key exclusion criteria (14 listed)
- Patient has a mental or physical condition that would invalidate evaluation results.
- Patient has had prior lumbar surgery at any level.
- Patient is scheduled to have more than one level of steroid injection.
- Patient is pregnant
- Patient has systemic 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 |
|---|---|---|
| DexamethasoneAlso: dexpak10 mg/mL injected into lumbar spine, one level, one injection | Drug | Dexamethasone |
| methylprednisolone acetateAlso: Depo-Medrol80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time | Drug | methylprednisolone acetate |
Primary outcome
To Determine if One Medication is Better at Relieving Pain Than the Other.
Time frame: 12 wk post injection
Subjects will be asked to return at 2 wks, 6 wks and 12 weeks the above time points to complete outcome measurements questionnaires and undergo a neurological examination, the 12 weeks outcome should show improvement s/p injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Suehun Ho, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and methylprednisolone acetate in people with Lumbar Spine Disc Herniation and Lumbar Radiculitis, 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine if One Medication is Better at Relieving Pain Than the Other. (time frame: 12 wk post injection). 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 22 Nov 2023.