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BEHANDELING VAN CHRONISCHE DISCOGENE LAGE RUGPIJN MET METHYLEEN BLAUW.


- candidate number8509
- NTR NumberNTR2547
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2010
- Secondary IDs2010-09 / 2010-022025-15 ; METC MUMC / EudraCT
- Public TitleBEHANDELING VAN CHRONISCHE DISCOGENE LAGE RUGPIJN MET METHYLEEN BLAUW.
- Scientific TitleIntradiscal Methylene Blue Injection Treatment for Chronic Discogenic Low back pain.
- ACRONYMIMBI
- hypothesisIntradiscal Methylene blue injection(IMBI) treatment reduces the pain and improves the patients global perceived effect (PGPE) in patients suffering from chronic axial low back pain from discogenic origin and to prove that IMBI treatment is safe and causes little side effects.
- Healt Condition(s) or Problem(s) studiedLow back pain (LBP), Intradiscal
- Inclusion criteria1. 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);
3. A neurological exam without marked motor deficit;
4. Age between 18 and 65 years;
5. Pain intensity should be NRS 5 or higher;
6. In provocative discography Modified Dallas Criteria 1-4 7. A provoked pain of at least 7 (NRS) or 70% of maximum pain.
- Exclusion criteria1. 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);
3. Body Mass Index BMI of ≥ 35;
4. Weighted pain with NRS below 5;
5. Previous lumbar back surgery ( e.g. Laminectomy, discectomy or fusion);
6. Invasive intradiscal procedure previously performed at the same level;
7. 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;
8. Moderate to severe endplate degenerative changes at the affected levels;
9. Grade 1-2 spondylolisthesis;
10. Pregnancy;
11. Coagulopathy or oral anti-coagulant therapy;
12. Infection;
13. Patients incapable of following verbal or written instructions or with psychiatric problems potentially interfering with cooperation in the study;
14. Discography:
A. That shows a posterior annular disruption to extend into the outer annulus or beyond the confines of the outer annulus;
B. 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;
C. Pain provocation in disc at pressures >50 Psi above opening pressure;
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2011
- planned closingdate1-jul-2013
- Target number of participants63
- InterventionsThe first 15 patients are included in a prospective case series without randomization (pilot study). If in this pilot study MB proves to be effective and a RCT feasible, a RCT will start. Al patients with discogenic LBP follow a standardized treatment schedule. The conservative treatment consists of medication according the scheme of the World health organisation (WHO):
1. Step 1 (Paracetamol and eventually NSAIDís);
2. Step 2: Non-opioid medication: Tramadol.
Patients receive discography when there is no treatment effect. If a discography is positive the patient is included and, in case of the RCT, randomised into the MB or the placebo group.
After proper patient selection and informed consent patients are scheduled for this methylene blue (MB) study. All patients are to be intradiscally injected with 1 ml of methylene ( 10mg/ml) blue followed by injection of 1 ml 2% Lidocaine hydrochloride.

Randomized clinical trial:
1. MB group: 1 ml of methylene ( 10mg/ml) blue followed by injection of 1 ml 2% Lidocaine hydrochloride;
2. (RCT) Placebo group: 1 ml of isotonic saline , followed by injection of 1 ml 2% Lidocaine hydrochloride.
- Primary outcome1. Mean pain NRS; (Numeric rating scale) measured three times a day for 4 days;
2. Patients global perceived Effect (7point Likert scale);
3. Primary endpoint at 6 months.
- Secondary outcome1. Used analgesics;
2. Oswestry Disability Index;
3. Rand-36;
4. EuroQol;
5. Working status;
6. MPQ-DLV.
- Timepoints6, 12, 26, 52 and 104 weeks.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMSc. Josť Geurts
- CONTACT for SCIENTIFIC QUERIES J.W. Kallewaard
- Sponsor/Initiator Maastricht University Medical Centre, Department of Anesthesiology and pain management
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)8-10-2013: Gefinancierd door zonmw en wordt inmiddels in 2 centra meer uitgevoerd 31-3-2014: Removal of "D. Todd Wetzel classification grade 1, 4 and 5." in exclusion criteria. Change of point 6+7 in inclusion criteria (was "6. In discography Todd Wetzel classification grade 2 and 3;
7. A provoked pain of at least NRS 5.")- AB
- RECORD29-sep-2010 - 5-mrt-2017


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