The Randomized Clinical Trial (RCT) aims to prove the hypothesis that Intradiscal Methylene blue Injection is capable of better pain reduction than the best available treatment in patients suffering from axial low back pain of discogenic origin
Conditions
Interventions
Product Name: methylene blue
Product Code: 61-73-4
Pharmaceutical Form: Injection*
INN or Proposed INN: METHYLTHIONINIUM CHLORIDE
CAS Number: 61734
Concentration unit: mg/ml milligram(s)/millilitre
Co
Sponsors
MUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 discography Todd Wetzel classification grade 2 and 3 and a provoked pain of at least NRS 5 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 - Weighted 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: Appendix 1. - 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 - Todd Wetzel classification grade 1, 4 and 5.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Randomized Clinical Trial (RCT) aims to prove the hypothesis that Intradiscal Methylene blue Injection is capable of better pain reduction than the best available treatment in patients suffering from axial low back pain of discogenic origin;Secondary Objective: Secondary objective will be to prove that the treatment improves function and quality of life. ;Primary end point(s): Primary study parameter is pain at 6 months measured by the NRS according to Jensen (mean pain NRS; measured three times a day for 4 days,) NRS pain highest and lowest for back pain and the Patients Global Perceived Effect (GPE) measured by a 7 point Likert Scale. These parameters are registered at the standardized follow-up moments (6 weeks, 3, 6, and 12 months). Additional main study parameter of the Case series and RCT is also complications and side effects. Number of adverse and serious adverse events such as nerve damage or discitis. (Note: Both are theoretical possible but have not been reported until date) | — |
Countries
Netherlands
Outcome results
None listed