Advantages of the Paramedian Approach for Cervical Epidural Steroid Injections: A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- precipitous decrease
Study Overview
Brief Summary
Ligamentum flavum in the cervical region is thin or not fused at the midline. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs).
Detailed Description
Ligamentum flavum in the cervical region is thin or not fused at the midline. The distinct elastic resistance offered by the ligamentum flavum before entering the epidural space when using the loss of resistance (LOR) technique may be blunted or even absent. The investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a LOR in some patients. If so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (CESIs). Therefore, the investigators randomly divide our patients into 2 groups; the midline approach group and the paramedian group. Then, the investigators examine the patterns of the pressure changes at the moment of a puncture of the ligamentum flavum during CESIs.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 20 to 80 yr
- •Cervical radicular pain caused by herniated nucleus pulposus, spinal steonosis, or other conditions, including herpes zoster-associated pain and whiplash injury for more than 3 months
- •Pain intensity > 4 of maximum 10 NRS
- •Failure to improve with conservative treatment
- •Cervical epidural location of needle confirmed by the fluoroscopic images
Exclusion Criteria
- •Acute infection
- •Patient refusal
- •Previous cervical spine surgery
- •Structural spinal deformities or A space-occupying epidural mass
- •Rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms that should prompt a reevaluation and surgical evaluation
- •Pregnancy
- •Allergy to contrast media or drugs to be used in the procedure
Outcomes
Primary Outcomes
precipitous decrease
Time Frame: It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
Existence of the precipitous decrease in pressure at the moment of entering the cervical epidural space (exist or not)
Secondary Outcomes
- popping sensation(It will be measured at the moment of puncture of ligamentum flavum during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.)
- spreading levels of dye according to dye volume(It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.)
- cervical epidural pressure(It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.)