Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00370994|
Recruitment Status : Completed
First Posted : September 1, 2006
Results First Posted : November 23, 2015
Last Update Posted : November 23, 2015
Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group.
Compare adverse event profile in both groups
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Procedure: Caudal epidural injection Procedure: Percutaneous adhesiolysis||Not Applicable|
Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections.
Single-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||April 2013|
Active Comparator: Caudal epidural injection
Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
Procedure: Caudal epidural injection
Caudal epidural injection with catheterization
Active Comparator: Percutaneous adhesiolysis
Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
Procedure: Percutaneous adhesiolysis
Percutaneous adhesiolysis with hypertonic saline neurolysis
- Numeric Pain Rating Score [ Time Frame: 3, 6, 12, 18 and 24 months post treatment. ]Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable
- Functional Status [ Time Frame: 3, 6, 12, 18 and 24 months post treatment. ]Oswestry Disability Index (ODI) - ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100 These patients are either bed-bound or exaggerating their symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370994
|United States, Kentucky|
|Ambulatory Surgery Center|
|Paducah, Kentucky, United States, 42003|
|Principal Investigator:||Laxmaiah Manchikanti, MD||Ambulatory Surgery Center|