An interventional study of Caudal Epidural Injection and percutaneous adhesiolysis in Low Back Pain, sponsored by Pain Management Center of Paducah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by Pain Management Center of Paducah · Not applicable, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Pain Management Center of Paducah is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
Procedure: Caudal Epidural Injection
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone
Procedure: percutaneous adhesiolysis
Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.
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.
List and look at all 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.
Plan to share: No
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Pain Management Center of Paducah