Analgesic Efficacy, Epidural, Lumbar Fixation, Lumbosacral Spondylolisthesis, Neuroplasty, Racz Catheter
Conditions
Brief summary
This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.
Detailed description
Lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. It often leads to back pain and neurologic symptoms. Epidural lysis of adhesions is a procedure which treat chronic LBP in patients which didn't respond to medical treatments.The technique of Radiofrequency ablation (RFA) uses high-frequency current to produce tissue coagulation and heat. It involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve
Interventions
PROCEDURERacz catheter
Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.
PROCEDUREClassic lumber fixation
Patients will undergo classic lumber fixation.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years. * Both sexes. * Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.
Exclusion criteria
* Uncooperative patients. * Patients in need of discectomy for lumber disc prolapse. * Patients with severe canal stenosis and in need of spinal laminectomy. * Contraindications to perform the proper technique e.g., coagulopathy and skin infection. * Body mass index (BMI) ≥35 kg/m2. * History of allergy to contrast medium. * Previously operated traditional spine surgeries.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Disability | 6 month post-procedure | Degree of Disability will be assessed using 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 6 month post-procedure | Each patient will be instructed about postoperative pain assessment with the visual analogue scale (VAS). VAS (0 represents no pain while 10 represents the worst pain imaginable). VAS will be assessed pre-procedure as baseline, immediately post-procedure, 1, 2, 4, 6 month post-procedure |
| Degree of patient satisfaction | 6 month post-procedure | 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) |
| Incidence of complications | 6 month post-procedure | Incidence of 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. |
Countries
Egypt
Outcome results
None listed