Effectiveness of Transgrade vs Interlaminar Epidural Steroid Injection for Chronic Unilateral Lumbar Radicular Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of patients who experienced successful pain relief at 3 month post-intervention
Study Overview
Brief Summary
Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •> 6-month history of persistent pain in one leg with back pain.
- •Capable of giving informed consent.
- •Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.
Exclusion Criteria
- •Previous lumbar spinal surgery.
- •Myelopathy.
- •Rheumatoid disorders.
- •Psychiatric disorders
- •Bleeding or coagulation disorders
Arms & Interventions
Interlaminar technique (IL)
Intervention: Interlaminar technique (IL) (Other)
Transgrade technique (TG)
Intervention: Transgrade technique (TG) (Other)
Outcomes
Primary Outcomes
Number of patients who experienced successful pain relief at 3 month post-intervention
Time Frame: 6 month post intervention (study period)
Number of patients who experienced successful pain relief at 3 month post-intervention, which is defined as ≥ 50% reduction of numeric rating scale (NRS-11) from pre-intervention level.
The average numeric rating scale (NRS) pain scores
Time Frame: at 12 weeks after intervention
The numeric rating scale (NRS) is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Secondary Outcomes
No secondary outcomes reported
Investigators
Ibrahim Mamdouh Esmat
Assistant Professor of Anesthesia, Intensive Care and Pain Management Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Ain Shams University