A Clinical Comparison in Cervical Epidural Pressure Changes Between Midline and Paramedian Approaches

Seoul National University

Status: Unknown

Conditions: Whiplash Injury; Herniated Nucleus Pulposus

Treatments: Procedure: Cervical epidural steroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01360138

jymoon0901

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

midline approach

Active Comparator group

Description:

cervical epidural steroid injection with 18G Touhy epidural needle by midline approach

Treatment:

Procedure: Cervical epidural steroid injection

paramedian approach

Active Comparator group

Description:

cervical epidural steroid injection with 18G Touhy epidural needle by paramedian approach

Treatment:

Procedure: Cervical epidural steroid injection