Role of Steroids and 10% Hypertonic Sodium Chloride in Adhesiolysis in Post Lumbar Surgery Syndrome Patients
| Status: | Completed |
|---|---|
| Conditions: | Back Pain, Back Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/26/2017 |
| Start Date: | February 2010 |
| End Date: | January 2014 |
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
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.
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.
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.
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.
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