Low Back Pain
Conditions
Keywords
Chronic low back pain, Post lumbar laminectomy syndrome, Lower extremity pain, Local anesthetic, Steroid, Percutaneous lumbar adhesiolysis
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREAdhesiolysis
Group I will receive adhesiolysis, local anesthetic, 10% sodium chloride solution, and non-particulate Celestone
Sponsors
Pain Management Center of Paducah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS), Oswestry Disability Index (ODI), | Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment. | duration of significant pain relief, opioid intake, and return to work |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event profile of 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. | Record side effects and any complications |
Countries
United States
Outcome results
None listed