Comparison of Pain score and Treatment effect between Bolus infusion method and Continuous infusion method when Hypertonic saline infusion in epidural adhesiolysis
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0003321
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
(1) patients between 18 and 80 years of age; (2) patients with a history of chronic low back pain and/or lower extremity radiating pain of at least 6 months; (3) patients who received lumbar epidural adhesiolysis with a 1-day protocol including hypertonic saline infusion; (4) patients with numerical rating scale (NRS) pain scores of 6 or more after appropriate conservative treatments, such as oral analgesics, physical therapy and epidural steroid injection.
(1) complaints of back pain more severe than leg pain; (2) lack of correlation between neuropathic back pain with radicular symptoms and MRI findings; (3) lumbar surgical intervention in previous 6 months; (4) coagulopathy, chronic infection or skin infection at the procedure site; (5) poorly controlled psychiatric disorders or acute medical illness, underlying systemic diseases that could interfere with the interpretation of the outcome assessments; (6) pregnant or lactating women; (7) with a history of adverse reaction to local anesthetics or steroids; (8) patients who require other interventions with uncontrolled pain during the follow-up period; (9) patients unable to understand the informed consent and protocol and (10) patients unable to be positioned in prone position to perform the procedure.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in changes in the 11-point NRS scores (0 = no pain, 10 = unbearable pain) induced by hypertonic saline infusion between patients in the 2 groups.
- Secondary Outcome Measures
Name Time Method The difference in changes in the 11-point NRS scores (0 = no pain, 10 = unbearable pain) of low back and/or lower extremity pain between patients in the 2 groups.;The difference in changes in the ODI between patients in the 2 groups.