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To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.
This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions.
Patients are studied in 2 groups in each region.
All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylocaine | Active Comparator | 0.5% Xylocaine |
|
| Xylocaine and Celestone | Active Comparator | 0.5% Xylocaine with 6 mg of non-particulate Celestone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylocaine | Drug | 0.5% Xylocaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids | examined improvements between those who received and did not receive steroids | Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. | examined differences between those who received and did not receive steroids | Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laxmaiah Manchikanti, MD | Ambulatory Surgery Center, Paducah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Surgery Center | Paducah | Kentucky | 42001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24077193 | Derived | Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. A randomized, double-blind, active control trial of fluoroscopic cervical interlaminar epidural injections in chronic pain of cervical disc herniation: results of a 2-year follow-up. Pain Physician. 2013 Sep-Oct;16(5):465-78. | |
| 22270749 | Derived | Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic epidural injections in cervical spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):E59-70. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Randomly assigned to groups
| Xylocaine and Celestone |
| Drug |
non-particulate Celestone |
|
|
| To evaluate and compare the adverse event profile in all patients. | examined adverse event differences between those who received and did not receive steroids | Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. |
| 22270734 | Derived | Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic cervical interlaminar epidural injections in managing chronic pain of cervical postsurgery syndrome: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):13-25. |
| 21102973 | Derived | Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A preliminary report of a randomized double-blind, active controlled trial of fluoroscopic thoracic interlaminar epidural injections in managing chronic thoracic pain. Pain Physician. 2010 Nov-Dec;13(6):E357-69. |
| 20648213 | Derived | Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):E265-78. |
| 20495586 | Derived | Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. The effectiveness of fluoroscopic cervical interlaminar epidural injections in managing chronic cervical disc herniation and radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 May-Jun;13(3):223-36. |
A Randomized, Double-Blind, Active Control Trial of Fluoroscopic Cervical Interlaminar Epidural Injections in Chronic Pain of Cervical Disc Herniation: Results of a 2-Year Follow-Up |
| Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |