Status:
UNKNOWN
Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?
Lead Sponsor:
Willy Halim
Conditions:
Contained Cervical Disc Herniation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral medications. Once these treatments have failed, different alternative procedures can be applied to relief pain. Th...
Eligibility Criteria
Inclusion
- Patients are legally competent and able to understand the nature, scope and aim of the clinical investigation and have given written informed consent to participate;
- Patients of either sex and of all races have been diagnosed with radiographically confirmed contained cervical disc herniation on MRI at one level;
- Patients received a diagnostic block;
- Patients failed conservative therapy during at least six weeks;
- Patients have complaints of radicular pain with or without neck pain, corresponding the herniated level;
- Patients score \>=50 mm on 100 mm Visual Analogue Scale for pain (VAS-100 mm);
- Patients are able and willing to return for follow-up evaluations;
- Patients have a stable drug regime.
Exclusion
- Patients have contraindications for intervention with PCN or PRF;
- Patients have been diagnosed with an extruded or sequestered disc fragment, spondylolisthesis, vertebral fracture or spinal stenosis;
- Patients have been diagnosed with uncovertebral or facet arthrosis;
- Patients underwent previous surgery or received any type of infiltrations at the indicated cervical level;
- Patients diagnosed with a contained cervical disc herniation \>1/3 spinal canal;
- Patients with radiographically confirmed loss of \>30% of disc height compared to adjacent level;
- Patients with evidence of severe disc degeneration;
- Patients suffer from uncontrolled psychological disorders;
- Patients suffer from unstable medical condition.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01797172
Start Date
October 1 2012
End Date
July 1 2014
Last Update
February 22 2013
Active Locations (1)
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1
Department of Anesthesia and Pain Management; St. Anna Hospital
Geldrop, North Brabant, Netherlands, 5664 EH