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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370994
First Posted: September 1, 2006
Last Update Posted: November 23, 2015
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.
Information provided by (Responsible Party):
Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
  Purpose

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 Intervention
Low Back Pain Procedure: Caudal epidural injection Procedure: Percutaneous adhesiolysis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis

Resource links provided by NLM:


Further study details as provided by Laxmaiah Manchikanti, MD, Pain Management Center of Paducah:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 120
Study Start Date: January 2006
Study Completion Date: April 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Kentucky
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42003
Sponsors and Collaborators
Pain Management Center of Paducah
Investigators
Principal Investigator: Laxmaiah Manchikanti, MD Ambulatory Surgery Center
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier: NCT00370994     History of Changes
Other Study ID Numbers: protocol 11
First Submitted: August 30, 2006
First Posted: September 1, 2006
Results First Submitted: March 21, 2012
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015
Last Verified: October 2015

Keywords provided by Laxmaiah Manchikanti, MD, Pain Management Center of Paducah:
post-lumbar surgery syndrome
percutaneous lumbar epidural adhesiolysis
hypertonic saline neurolysis

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms