Effectiveness of Cervical Facet Joint Nerve Blocks
To demonstrate whether:
i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect.
ii. Adjuvant medications (Sarapin and Depo-Medrol) provide additional relief of cervical facet joint pain when used with facet joint nerve blocks.
- To demonstrate whether or not there are clinically significant improvements in function of patients who receive cervical facet joint nerve block with or without Sarapin and Depo-Medrol (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
- To determine the adverse event profile in both groups.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Effectiveness of Cervical Facet Joint Nerve Blocks: A Randomized, Prospective, Double-Blind Controlled Evaluation|
- To demonstrate a clinically significant difference between the patients treated with adjuvants and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18and 24 months post treatment;
- To assess adverse events in all patients.
|Study Start Date:||September 2003|
|Study Completion Date:||March 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
|United States, Kentucky|
|Ambulatory Surgery Center|
|Paducah, Kentucky, United States, 42003|
|Principal Investigator:||Laxmaiah Manchikanti, MD|