Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to compare Racz catheter technique and conventional technique in lumbar epidural steroid injection for the management of low back pain.
Low back pain (LBP) is defined as a localized discomfort sensation below the costal margin and above the inferior gluteal folds, with or without leg pain. Conservative treatment for LBP is focused on delaying or preventing the need for surgery. Indeed, LBP can improve spontaneously or with non-surgical treatment. However, cases that fail to improve with conservative management may need to be considered for a surgical approach.
The epidural injection is a well-founded anesthetic and analgesic technique; moreover, nowadays, new technological devices can help anesthesiologists to learn and to administer it. One of these devices is Racz catheter epidural adhesiolysis. Racz catheter epidural adhesiolysis treatment addresses two issues, the injectate always reaches the area being targeted also the injections are likely to loosen fibrotic adhesions which may be the main cause of the pain in some cases.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional lumbar steroid injections group | Active Comparator | Patients will receive conventional lumbar steroid injections. |
|
| Racz catheter group | Experimental | Patients will receive lumbar epidural steroid using Racz catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional lumbar steroid injections | Drug | Patients will receive conventional lumbar steroid injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry score | Oswestry Low Back Disability Questionnaire: This questionnaire has been designed to give us information as to how back pain has affected a patient's ability to manage everyday life. It consists of 10 questions for each question, there is a possible 5 points (0 for the first answer, 1 for the second answer, etc). Add up the total for the 10 questions and rate them on the scale (0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability). It will be assisted pre-procedure as a baseline, after 1, 2, 4, 6 month post-procedure. | 6 month post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of pain | The degree of pain will be assessed using the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). | 6 month post-procedure |
| Patient satisfaction |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Racz catheter | Procedure | Patients will receive lumbar epidural steroid using Racz catheter. |
|
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
| 6 month post-procedure |
| Procedure technique time | The time consumed to perform both techniques will be recorded. | Intraoperatively |
| Incidence of complications | Complications that may occur during the technique such as (bending of the tip of the needle, shearing of the catheter, misplacement of the catheter, blocking of the catheter, blood aspiration and bleeding in the epidural space, hypotension, migration of the catheter, paresthesia, headache and infection) will be recorded. | 6 month post-procedure |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided