BEHANDELING VAN CHRONISCHE DISCOGENE LAGE RUGPIJN MET METHYLEEN BLAUW.
- Conditions
- axial lumbar low back pain discus discogenic intradiscal lage rug pijn lumbaal tussenwervelschijf
- Registration Number
- NL-OMON26862
- Lead Sponsor
- MUMC-Maastricht University Medical CentreDepartment of Anesthesiology and pain managementPO Box 58006202 AZ MaastrichtThe Netherlands. Addition 8-10-2013: Financed by ZonMW. The study is carried out in 2 additional centra.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 63
1. Axial low back pain of presumed discogenic origin of at least 6 months duration and non responsive to treatment of at least 6 months conservative medical management;
2. History consistent with discogenic low back pain ( e.g. predominant axial pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance);
1. Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI;
2. Extruded or sequestered herniated nucleus pulposus at the affected level(s);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mean pain NRS; (Numeric rating scale) measured three times a day for 4 days;<br /><br>2. Patients global perceived Effect (7point Likert scale);<br /><br>3. Primary endpoint at 6 months.
- Secondary Outcome Measures
Name Time Method 1. Used analgesics;<br /><br>2. Oswestry Disability Index;<br /><br>3. Rand-36;<br /><br>4. EuroQol;<br /><br>5. Working status;<br /><br>6. MPQ-DLV.