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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 Pain Management Center of Paducah:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 30, 2006
Results First Received: March 21, 2012
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 01, 2016