None listed
Conditions
Interventions
Medical Device : After performing lumbar epidural adhesiolysis, 6 mL of 10%
NaCl solution was injected through epidural catheter by the following method. In the bolus group, 1.5 ml of 10%
hypertonic saline was injected slowly through epidural catheter four times every 15 minutes. 1.5 ml of hypertonic saline was administered slowly over 5 - 10 seconds. In the continuous infusion group,
hypertonic saline was continuously infused for 60 minutes through an infusion pump connected to the epidural catheter.
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Korea, Republic of
Contacts
Public ContactPyung-Bok LEE
Seoul National University Bundang Hospital
Outcome results
None listed