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. * Group I-local anesthetic only. * Group II-local anesthetic with 6 mg of non-particulate Celestone. 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 Non-responsive patients may be unblinded and withdrawn from the study at any time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
0.5% Xylocaine
non-particulate Celestone
Ambulatory Surgery Center
Paducah, Kentucky, United States
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
Time frame: 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.
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
Time frame: 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.
To evaluate and compare the adverse event profile in all patients.
examined adverse event differences between those who received and did not receive steroids
Time frame: 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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