Status:

COMPLETED

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

Lead Sponsor:

Pain Management Center of Paducah

Conditions:

Low Back Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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...

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 chiroprac...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2013

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00370994

Start Date

January 1 2006

End Date

April 1 2013

Last Update

March 10 2020

Active Locations (1)

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1

Ambulatory Surgery Center

Paducah, Kentucky, United States, 42003