A Prospective Clinical Series followed by A Multicenter Double-blind Randomised Placebo-Controlled Clinical Trial
- Conditions
- 10043237discogene lage rugklachtenLow Back Paindiscogenic pijn
- Registration Number
- NL-OMON46869
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
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.;History consistent with discogenic low back pain ( e.g. predominant axial pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance) A neurological exam without marked motor deficit. Age between18 and 65 years and painintensity should be NRS 5 or higher. In provocative discography Modified Dallas classification grade 1 to 4 and a provoked pain of at least NRS 7 or >=70% of worst pain.
Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.;- Extruded or sequestered herniated nucleus pulposus at the affected level(s).;- Body Mass Index BMI of >= 35;- Mean pain with NRS below 5;- Previous lumbar back surgery ( e.g. Laminectomy, discectomy or fusion);- Invasive intradiscal procedure previously performed at the same level.;- Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT, provided stenosis is the cause of pain.;- Moderate to severe endplate degenerative changes at the affected levels;- Grate 1-2 spondylolisthesis;- Pregnancy;- Coagulopathy or oral anti-coagulant therapy;- Infection;- Patients incapable of following verbal or written instructions or with psychiatric problems potentially interfering with cooperation in the study;- Discography: ;That shows a posterior annular disruption to extend into the outer annulus or beyond the confines of the outer annulus.;-;Discography without pain reproduction at the affected level( s), or with discordant pain at adjacent unaffected levels at up to 50 Psi above opening pressure.;-;Pain provocation in disc at pressures >50 Psi above opening pressure;-;In provocative discography Modified Dallas classification grade 0 and 5.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter is pain at 6 months measured by the NRS according to<br /><br>Jensen (Jensen and McFarland 1993)(mean pain NRS; measured three times a day<br /><br>for 4 days,) and the Patients Global Perceived Effect (PGIC) measured by the 7<br /><br>point Likert Scale (Farrar, Young et al. 2001)<br /><br>These parameters are registered at baseline and at the standard follow-up<br /><br>moments (6 weeks, 3, 6, 12, 24 months).<br /><br>Main study parameter of the CS and RCT is also complications and side<br /><br>effects.(Dworkin, Turk et al. 2005) Number of adverse and serious adverse<br /><br>events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints<br /><br>-Disability measured by the Oswestry Disability Index(Baker, Pynsent et al.<br /><br>1989)<br /><br>-Quality of life measured by the Rand-36(Ware and Sherbourne 1992; Dworkin,<br /><br>Turk et al. 2005)<br /><br>-Cost effectiveness.<br /><br>-Used analgesics<br /><br>-MPQ-DLV (McGill Pain Questionnaire- Dutch Language Version).(Melzack 1987)<br /><br><br /><br>Other study parameters<br /><br>After informed consent baseline values of possible confounders are registered:<br /><br>-Demographics, length, weight, BMI<br /><br>-Neurological status<br /><br>-MPI-DLV (pain related psychosocial and behavioral aspects)(Dworkin, Turk et<br /><br>al. 2005)<br /><br>-MRI<br /><br><br /><br>Tertiary parameters:<br /><br>- MRI classification (Pfirrmann grading scale, Modic Changes, High Intensity<br /><br>Zone).</p><br>