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To evaluate the effectiveness of steroids and/or 10% hypertonic sodium chloride in percutaneous adhesiolysis in managing chronic low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
To evaluate and compare the adverse event profile in all groups.
Recruitment is indicated in patients with chronic low back pain and lower extremity pain secondary to post lumbar laminectomy syndrome, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections.
This is a single-center, prospective, randomized, double-blind, equivalence, controlled trial performed in an interventional pain management referral center in the United States.
The study involves 240 patients studied in 4 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding.
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 |
|---|---|---|---|
| Celestone | Active Comparator | Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone |
|
| sodium chloride solution | Active Comparator | Group II will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and 0.9% sodium chloride solution to substitute for non-particulate Celestone |
|
| sodium choride solution | Active Comparator | Group III will receive adhesiolysis, local anesthetic, normal sodium chloride solution instead of 10% hypertonic sodium chloride solution and non-particulate Celestone; |
|
| Double substitutes | Active Comparator | Group IV will receive adhesiolysis, local anesthetic, and 0.9% sodium chloride solution to substitute for the 10% hypertonic sodium chloride, and 0.9% sodium chloride solution to substitute for non-particulate Celestone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhesiolysis | Procedure | Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone |
|
| 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. | Record side effects and any 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:
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laxmaiah Manchikanti, MD | PMC of Paducah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Management Center of Paducah | Paducah | Kentucky | 42001 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
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|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005159 |
| Health Care Facilities Workforce and Services |