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| Name | Class |
|---|---|
| Walter Reed Army Medical Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Active Comparator | Two epidural steroid injections two weeks apart based on history and physical exam alone |
|
| II | Active Comparator | Two epidural steroid injections two weeks apart based on history, physical exam and MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural steroid injection | Procedure | Injection based solely on history and physical exam |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change in numerical rating leg pain score | 1 month after 2nd epidural injection |
| Measure | Description | Time Frame |
|---|---|---|
| change in numerical rating back pain score | 1 month after 2nd epidural injection | |
| change in numerical rating scale leg pain score | Pain score 3 months after 2nd epidural steroid injection | 3 months after 2nd epidural steroid injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven P Cohen, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States | ||
| Johns Hopkins School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11179160 | Background | 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. | |
| 15031430 | Background | Gilbert 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. |
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| Epidural steroid injection |
| Procedure |
Two epidural steroid injections two weeks apart based on history, physical exam and MRI |
|
| Magnetic Resonance Imaging (MRI) | Procedure | Imaging of lumbar spine |
|
| Change in numerical rating scale back pain score | Back pain 3 months after epidural steroid injections | 3 months after 2nd epidural steroid injection |
| Change in Oswestry disability index | Measurement of functional capacity 1 month after 2nd epidural steroid injection | 1 month after 2nd epidural steroid injection |
| Change in Oswestry disability index | Measurement of functional capacity 3 months after 2nd epidural steroid injection | 3 months after 2nd epidural steroid injection |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| 16244269 | Background | Modic 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. |
| 19103627 | Background | Cohen SP, Argoff CE, Carragee EJ. Management of low back pain. BMJ. 2008 Dec 22;337:a2718. doi: 10.1136/bmj.a2718. No abstract available. |
| 22157067 | Derived | Cohen 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. |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D009437 | Neuralgia |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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