Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients
This trial is active, not recruiting.
|Condition||low back pain|
|Sponsor||Pain Management Center of Paducah|
|Start date||February 2010|
|End date||January 2012|
|Trial size||240 participants|
|Trial identifier||NCT01053572, Protocol 23|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver)|
Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work
time frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.
Adverse event profile of side effects and complications.
time frame: 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.
Male or female participants at least 18 years old.
Inclusion Criteria: Inclusion criteria: - History of lumbar surgery of at least 6 months duration in the past - Patients over the age of 18 years - Patients with a history of chronic function-limiting low back pain with or without lower extremity pain of at least 6 months duration (post-surgery) - Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements. Exclusion criteria: - Facet joints, uncontrollable as sole pain generators - Unstable or heavy opioid use (400 mg of morphine equivalents daily) - Uncontrolled psychiatric disorders - Uncontrolled medical illness - Any conditions that could interfere with the interpretation of the outcome assessments - Pregnant or lactating women - Patients with a history or potential for adverse reaction(s) to local anesthetic, steroids, or hypertonic sodium chloride solution.
|Official title||Evaluation of the Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients: A Prospective, Randomized, Double-Blind, Equivalence, Controlled Trial of Percutaneous Lumbar Adhesiolysis|
|Principal investigator||Laxmaiah Manchikanti, MD|
|Description||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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