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The purpose of this study is to:
Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.
This is a single-center study performed in an interventional pain management referral center in the United States.
The study involves 120 patients assigned to one of 2 groups with 60 patients in each group.
Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value < 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caudal epidural Injection | Active Comparator | Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution |
|
| Percutaneous Adhesiolysis | Active Comparator | Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal Epidural Injection | Procedure | Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating scale (NRS), Oswestry Disability Index (ODI) | duration of significant pain relief, opioid intake, and return to work | Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event profile of side effects and complications. | List and look at all side effects and complications | Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laxmaiah Manchikanti | Ambulatory Surgery Center, Paducah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Management Center of Paducah | Paducah | Kentucky | 42001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20309389 | Derived | Manchikanti L, Pampati V, Cash KA. Protocol for evaluation of the comparative effectiveness of percutaneous adhesiolysis and caudal epidural steroid injections in low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Pain Physician. 2010 Mar-Apr;13(2):E91-E110. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| percutaneous adhesiolysis | Procedure | Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |