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Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. By assessing the relative efficacy of transforaminal epidural injections of particulate and nonparticulate steroids, this study attempts to further define the appropriate conservative management of painful unilateral radiculopathies due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months following the injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decadron | Active Comparator | Patients in the Decadron group will receive epidural injections containing a total of 15 mg Decadron. |
|
| Kenalog | Active Comparator | Patients in the Kenalog group will receive epidural injections containing a total of 80 mg Kenalog. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kenalog Injectable Product | Drug | 80 mg of Kenalog will be used. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in function (2 weeks post-injection) | This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 2 weeks post-injection |
| Improvement in function (6 weeks post-injection) | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 6 weeks post-injection |
| Improvement in function (3 months post-injection) | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 3 months post-injection |
| Improvement in function (6 months post-injection) | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). | 6 months post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Medication use | The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected. | 2 weeks, 6 weeks, 3 months, and 6 months post-injection |
| Patient satisfaction with the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Decadron Phosphate, Injectable |
| Drug |
15 mg of Decadron will be used. |
|
| Epidural Steroid Injection | Procedure | Patient will receive epidural steroid injections of either Kenalog or Decadron. |
|
Satisfaction will be assessed using the North American Spine Society Outcome Questionnaire. Patients will be asked to pick from 4 multiple choice statements regarding their satisfaction with their procedure.
| 2 weeks, 6 weeks, 3 months, and 6 months post-injection |
| Quality of life | This will be assessed using the Veterans RAND 12-item Health Survey. | 2 weeks, 6 weeks, 3 months, and 6 months post-injection |
| Side effects | Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected. | 2 weeks, 6 weeks, 3 months, and 6 months post-injection |