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Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:
NCT00370994
First received: August 30, 2006
Last updated: October 20, 2015
Last verified: October 2015

August 30, 2006
October 20, 2015
January 2006
December 2009   (final data collection date for primary outcome measure)
Numeric Pain Rating Score [ Time Frame: 3, 6, 12, 18 and 24 months post treatment. ] [ Designated as safety issue: No ]
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable
To evaluate for difference between the patients in various groups in the physical function and pain at 3, 6, 12, 18 and 24 months post treatment.
Complete list of historical versions of study NCT00370994 on ClinicalTrials.gov Archive Site
Functional Status [ Time Frame: 3, 6, 12, 18 and 24 months post treatment. ] [ Designated as safety issue: Yes ]
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 assess adverse events in both groups.
Not Provided
Not Provided
 
Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain
A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Low Back Pain
  • Procedure: Caudal epidural injection
    Caudal epidural injection with catheterization
  • Procedure: Percutaneous adhesiolysis
    Percutaneous adhesiolysis with hypertonic saline neurolysis
  • 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
    Intervention: Procedure: Caudal epidural injection
  • 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
    Intervention: Procedure: Percutaneous adhesiolysis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
April 2013
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Over 18 years of age
  • History of chronic, function limiting low back pain of at least 6 months in duration
  • Able to give voluntary, written informed consent
  • Able to understand investigational procedures and willing to return for follow-ups
  • No recent surgical procedures within last 3 months

Exclusion Criteria:

  • Large contained or sequestered herniation
  • Cauda Equina symptoms and/or compressive radiculopathy
  • Narcotic use of no greater than 100mg/day Hydrocodone, 60mg Methadone, or 100mg Morphine
  • Uncontrolled major depression or psychiatric disorder
  • Uncontrolled or acute medical illness
  • Chronic sever conditions that could interfere with outcome assessments
  • Women who are pregnant or lactating
  • Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00370994
protocol 11
Yes
Not Provided
Not Provided
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
Pain Management Center of Paducah
Not Provided
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center
Pain Management Center of Paducah
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP