- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837070
Percutaneous Rupture of Zygapophyseal Joint Cysts
September 26, 2017 updated by: Therese Seierstad, Ullevaal University Hospital
Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy.
These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture.
30 patient with lower extremity radiculopathy caused by lumbar zygapophyseal joint cysts will be included in the study.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0407
- Departement of Neuroradiology Oslo university hospital avd Ullevaal
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with lumbar zygapophyseal joint cyst and compression of a spinal nerve root with lower extremity radiculopathy proven by MRI.
Exclusion Criteria:
- Infection, uncontrollable bleeding disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Percutaneous zygapophyseal cyst rupture
|
Patients will be treated by introducing a 20G spinal needle in the inferior joint recess of the zygapophyseal joint.1 ml of celestone-chronodose,1 ml of Marcain 5 mg/ml and 1-3 ml of contrast media:Omnipaque 240 will be injected until the cyst ruptures.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
VAS(Visual analogue scale)for extremity pain
Time Frame: 1-3 and 12 months after intervention
|
1-3 and 12 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Roland-Morris disability index
Time Frame: 1-3 and 12 months after intervention
|
1-3 and 12 months after intervention
|
Reduction of cyst size based om T2 MRI
Time Frame: 3 and 12 months after intervention
|
3 and 12 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Øivind Gjertsen, Md, Msc, Oslo University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 5, 2009
Study Record Updates
Last Update Posted (Actual)
September 28, 2017
Last Update Submitted That Met QC Criteria
September 26, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 264-07111a 2007.345
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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