Trials / Completed
CompletedNCT00370994
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Pain Management Center of Paducah · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Caudal epidural injection | Caudal epidural injection with catheterization |
| PROCEDURE | Percutaneous adhesiolysis | Percutaneous adhesiolysis with hypertonic saline neurolysis |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2009-12-01
- Completion
- 2013-04-01
- First posted
- 2006-09-01
- Last updated
- 2020-03-10
- Results posted
- 2015-11-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00370994. Inclusion in this directory is not an endorsement.