Lumbosacral RadiculopathyNCT00826124
Does Magnetic Resonance Imaging (MRI) Improve Interventional Outcomes for Lumbosacral Radiculopathy?
A study testing Epidural steroid injection and Magnetic Resonance Imaging (MRI) in people with Lumbosacral Radiculopathy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Epidural steroid injections (ESI) are the most frequently performed procedures in pain clinics. When performing ESI, there is no consensus about how to best select candidates for this intervention, and which level(s) to inject. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- Epidural steroid injection and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Feb 2011
- 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
- Age > 18
- Candidates for ESI based on history and physical exam
- NRS pain score > 4
- Leg pain > back pain
- Patients already have an MRI
Who cannot join
- Untreated coagulopathy
- Previous spine surgery
- Leg pain > 4 years duration
- Epidural steroid injection within past 2 years
- Serious (e.g., bowel or bladder incontinence, loss of reflexes) or progressive neurological deficit
- Referrals from surgery diagnostic injections for surgical evaluation
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- Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
- Pregnancy
- Serious underlying pathology (e.g., vertebral fracture, spinal infection or metastases), as determined by an independent reviewer (group I) or the treating physician (group II) on MRI. The investigator and injector for group I patients will remain blinded to this review except to know that serious pathology was ruled out.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: Does MRI Improve Interventional Outcomes for Lumbosacral Radiculopathy? A Randomized Study Comparing Epidural Steroid Injections Based on Clinical Findings Alone, or Clinical Findings and MRI
Epidural steroid injections (ESI) are the most frequently performed procedures in pain clinics. When performing ESI, there is no consensus about how to best select candidates for this intervention, and which level(s) to inject. Some experts advocate basing the injection level on MRI findings, whereas others recommend clinical symptoms. In order to determine whether MRI is necessary before referring patients with chronic LBP radiating into the leg(s) for pain management interventions, we will perform a randomized comparative study involving 131 patients with chronic low back and leg pain who are clinically candidates for epidural steroid injections into two groups. Group I will receive two ESI based solely on historical and physical exam (PE) findings. Group II will receive treatment only after MRI is reviewed.
The investigators' hypothesis is that MRI will not have a significant effect on treatment outcome, and will have minimal impact on patient care.
Read the detailed description
One hundred and thirty-one patients referred to the Blaustein Pain Treatment Center with back and leg pain will be randomized to receive one of two treatments. Sixty-three patients will be allocated to group I and up to 68 to group II (see below and statistical analysis). All patients will be candidates for ESI based on history and physical exam. All 63 group I patients will receive two ESI based solely on history and PE (i.e. the treating physician will be blinded to MRI results). Group II will receive treatment based on MRI, history and PE. This probably but may not include ESI (i.e. it is conceivable that a normal MRI might result in conventional therapy instead of ESI, though chemical irritation of nerve roots often occurs without disc protrusion. We estimate this to occur in no more than 10% of cases (probably less); hence, we are planning to randomize up to 68 patients to group II. If an ESI is done, the patient will receive two injections, similar to patients in group I. Randomization will be done by a research assistant via a computerized randomization system in groups of 13. In order to ensure no serious pathology is missed in group I subjects, a separate doctor with no knowledge of treatment allocation will review the films. If there is serious pathology such as evidence of spinal metastases or infection, the patient will be excluded from the study. There will be no "control" group in this study. Both evaluating physicians and patients will be blinded until they exit the study.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Epidural steroid injection, Magnetic Resonance Imaging (MRI)
- Keywords
- low back pain, radiculopathy, sciatica
- Medical subject headings
- Low Back Pain, Radiculopathy, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural steroid injectionProcedure or surgery
Injection based solely on history and physical exam
Epidural steroid injectionProcedure or surgery
Two epidural steroid injections two weeks apart based on history, physical exam and MRI
Magnetic Resonance Imaging (MRI)Procedure or surgery
Imaging of lumbar spine
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Two epidural steroid injections two weeks apart based on history and physical exam alone Receives: Procedure: Epidural steroid injection |
| II | Active comparator | Two epidural steroid injections two weeks apart based on history, physical exam and MRI Receives: Procedure: Epidural steroid injection; Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in numerical rating leg pain score
Measured: 1 month after 2nd epidural injection
Secondary outcomes (5)
change in numerical rating back pain score
Measured: 1 month after 2nd epidural injection
change in numerical rating scale leg pain score
Pain score 3 months after 2nd epidural steroid injection
Measured: 3 months after 2nd epidural steroid injection
Change in numerical rating scale back pain score
Back pain 3 months after epidural steroid injections
Measured: 3 months after 2nd epidural steroid injection
Change in Oswestry disability index
Measurement of functional capacity 1 month after 2nd epidural steroid injection
Measured: 1 month after 2nd epidural steroid injection
Change in Oswestry disability index
Measurement of functional capacity 3 months after 2nd epidural steroid injection
Measured: 3 months after 2nd epidural steroid injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Investigators
- Steven P Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826124
- Sponsor's protocol ID
- NA_00022479
- Status last verified
- Jan 2009
- First submitted
- 20 Jan 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kendrick D, Fielding K, Bentley E, Kerslake R, Miller P, Pringle M. Radiography of the lumbar spine in primary care patients with low back pain: randomised controlled trial. BMJ. 2001 Feb 17;322(7283):400-5. doi: 10.1136/bmj.322.7283.400.
PubMed 11179160Gilbert FJ, Grant AM, Gillan MG, Vale LD, Campbell MK, Scott NW, Knight DJ, Wardlaw D; Scottish Back Trial Group. Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial. Radiology. 2004 May;231(2):343-51. doi: 10.1148/radiol.2312030886. Epub 2004 Mar 18.
PubMed 15031430Modic MT, Obuchowski NA, Ross JS, Brant-Zawadzki MN, Grooff PN, Mazanec DJ, Benzel EC. Acute low back pain and radiculopathy: MR imaging findings and their prognostic role and effect on outcome. Radiology. 2005 Nov;237(2):597-604. doi: 10.1148/radiol.2372041509.
PubMed 16244269Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
PubMed 19103627Cohen SP, Gupta A, Strassels SA, Christo PJ, Erdek MA, Griffith SR, Kurihara C, Buckenmaier CC 3rd, Cornblath D, Vu TN. Effect of MRI on treatment results or decision making in patients with lumbosacral radiculopathy referred for epidural steroid injections: a multicenter, randomized controlled trial. Arch Intern Med. 2012 Jan 23;172(2):134-42. doi: 10.1001/archinternmed.2011.593. Epub 2011 Dec 12.
PubMed 22157067
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does MRI Improve Interventional Outcomes for Lumbosacral Radiculopathy? A Randomized Study Comparing Epidural Steroid Injections Based on Clinical Findings Alone, or Clinical Findings and MRI
- ClinicalTrials.gov ID
- NCT00826124
- Acronym / sponsor ID
- NA_00022479
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- low back pain, radiculopathy, sciatica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Walter Reed Army Medical Center
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Jan 2009 (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.
Epidural steroid injections (ESI) are the most frequently performed procedures in pain clinics. When performing ESI, there is no consensus about how to best select candidates for this intervention, and which level(s) to inject. Some experts advocate basing the injection level on MRI findings, whereas others recommend clinical symptoms. In order to determine whether MRI is necessary before referring patients with chronic LBP radiating into the leg(s) for pain management interventions, we will perform a randomized comparative study involving 131 patients with chronic low back and leg pain who are clinically candidates for epidural steroid injections into two groups. Group I will receive two ESI based solely on historical and physical exam (PE) findings. Group II will receive treatment only after MRI is reviewed.
The investigators' hypothesis is that MRI will not have a significant effect on treatment outcome, and will have minimal impact on patient care.
Detailed description
One hundred and thirty-one patients referred to the Blaustein Pain Treatment Center with back and leg pain will be randomized to receive one of two treatments. Sixty-three patients will be allocated to group I and up to 68 to group II (see below and statistical analysis). All patients will be candidates for ESI based on history and physical exam. All 63 group I patients will receive two ESI based solely on history and PE (i.e. the treating physician will be blinded to MRI results). Group II will receive treatment based on MRI, history and PE. This probably but may not include ESI (i.e. it is conceivable that a normal MRI might result in conventional therapy instead of ESI, though chemical irritation of nerve roots often occurs without disc protrusion. We estimate this to occur in no more than 10% of cases (probably less); hence, we are planning to randomize up to 68 patients to group II. If an ESI is done, the patient will receive two injections, similar to patients in group I. Randomization will be done by a research assistant via a computerized randomization system in groups of 13. In order to ensure no serious pathology is missed in group I subjects, a separate doctor with no knowledge of treatment allocation will review the films. If there is serious pathology such as evidence of spinal metastases or infection, the patient will be excluded from the study. There will be no "control" group in this study. Both evaluating physicians and patients will be blinded until they exit the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Procedure: Epidural steroid injectionTwo epidural steroid injections two weeks apart based on history and physical exam alone |
| II | Active comparator | Procedure: Epidural steroid injection, Procedure: Magnetic Resonance Imaging (MRI)Two epidural steroid injections two weeks apart based on history, physical exam and MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18
- Candidates for ESI based on history and physical exam
- NRS pain score > 4
- Leg pain > back pain
- Patients already have an MRI
Key exclusion criteria (9 listed)
- Untreated coagulopathy
- Previous spine surgery
- Leg pain > 4 years duration
- Epidural steroid injection within past 2 years
- Serious (e.g., bowel or bladder incontinence, loss of reflexes) or progressive neurological deficit
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 |
|---|---|---|
| Epidural steroid injectionInjection based solely on history and physical exam | Procedure or surgery | I |
| Epidural steroid injectionTwo epidural steroid injections two weeks apart based on history, physical exam and MRI | Procedure or surgery | II |
| Magnetic Resonance Imaging (MRI)Imaging of lumbar spine | Procedure or surgery | II |
Primary outcome
change in numerical rating leg pain score
Time frame: 1 month after 2nd epidural injection
5 secondary outcomes
change in numerical rating back pain score
Time frame: 1 month after 2nd epidural injection
change in numerical rating scale leg pain score
Time frame: 3 months after 2nd epidural steroid injection
Change in numerical rating scale back pain score
Time frame: 3 months after 2nd epidural steroid injection
Change in Oswestry disability index
Time frame: 1 month after 2nd epidural steroid injection
Change in Oswestry disability index
Time frame: 3 months after 2nd epidural steroid 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 23 Jun 2011.
- Background: PubMed 11179160Kendrick D, Fielding K, Bentley E, Kerslake R, Miller P, Pringle M. Radiography of the lumbar spine in primary care patients with low back pain: randomised controlled trial. BMJ. 2001 Feb 17;322(7283):400-5. doi: 10.1136/bmj.322.7283.400.
- Background: PubMed 15031430Gilbert FJ, Grant AM, Gillan MG, Vale LD, Campbell MK, Scott NW, Knight DJ, Wardlaw D; Scottish Back Trial Group. Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial. Radiology. 2004 May;231(2):343-51. doi: 10.1148/radiol.2312030886. Epub 2004 Mar 18.
- Background: PubMed 16244269Modic MT, Obuchowski NA, Ross JS, Brant-Zawadzki MN, Grooff PN, Mazanec DJ, Benzel EC. Acute low back pain and radiculopathy: MR imaging findings and their prognostic role and effect on outcome. Radiology. 2005 Nov;237(2):597-604. doi: 10.1148/radiol.2372041509.
- Background: PubMed 19103627Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available.
- Derived from this study: PubMed 22157067Cohen SP, Gupta A, Strassels SA, Christo PJ, Erdek MA, Griffith SR, Kurihara C, Buckenmaier CC 3rd, Cornblath D, Vu TN. Effect of MRI on treatment results or decision making in patients with lumbosacral radiculopathy referred for epidural steroid injections: a multicenter, randomized controlled trial. Arch Intern Med. 2012 Jan 23;172(2):134-42. doi: 10.1001/archinternmed.2011.593. Epub 2011 Dec 12.
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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.
Steven P Cohen, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural steroid injection and Magnetic Resonance Imaging (MRI) in people with Lumbosacral Radiculopathy, run by Johns Hopkins University 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 5 inclusion and 9 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 23 Jun 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?
change in numerical rating leg pain score (time frame: 1 month after 2nd epidural 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 NCT00826124, which also lists 5 linked publications.
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 23 Jun 2011; AzTrials last refreshed its copy on 6 Nov 2026.