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

Low Back Pain Clinical Trial

Official title:

A Randomized, Prospective, Double-blind Controlled Evaluation of the Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Hypertonic Saline Neurolysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370994
• Other study ID #: protocol 11
• Status: Completed
• Phase: N/A
• Start date: January 2006
• Est. completion date: April 2013

Study information

• Verified date: March 2020
• Source: Pain Management Center of Paducah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Caudal epidural injection
Caudal epidural injection with catheterization
• Percutaneous adhesiolysis
Percutaneous adhesiolysis with hypertonic saline neurolysis

Locations

Country	Name	City	State
United States	Ambulatory Surgery Center	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Pain Management Center of Paducah

Country where clinical trial is conducted

United States, 

References & Publications (1)

Manchikanti L, Singh V, Cash KA, Pampati V. Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial. J Pain Res. 2012;5:597-608. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Score	Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable	3, 6, 12, 18 and 24 months post treatment.
Secondary	Functional Status	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.	3, 6, 12, 18 and 24 months post treatment.

External Links

•   Assessment of effectiveness of percutaneous adhesiolysis and caudal epidural injections in managing post lumbar surgery syndrome: 2-year follow-up of a randomized, controlled trial.