Clinical trial NCT01360138: A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
Official title: Advantages of the Paramedian Approach for Cervical Epidural Steroid Injections: A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herniated Nucleus Pulposus
Whiplash Injury
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
First posted: 2011-05-25
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: precipitous decrease
timeFrame: 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.
Secondary outcomes:
measure: popping sensation
timeFrame: 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.
measure: spreading levels of dye according to dye volume
timeFrame: It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
measure: cervical epidural pressure
timeFrame: It will be measured during interventional procedure, then participants will be followed for the duration of hospital stay, an expected average of 1 hour.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: