axial lumbar low back pain discus discogenic intradiscal lage rug pijn lumbaal tussenwervelschijf
Conditions
Interventions
The 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
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 in
2. (RCT) Placebo group: 1 ml of isotonic saline , followed by injection of 1 ml 2% Lidocaine hydrochloride.
Sponsors
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.
Eligibility
Inclusion criteria
Inclusion criteria: 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); 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 criteria
Exclusion criteria: 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); 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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
| Measure | Time frame |
|---|---|
| 1. Used analgesics; 2. Oswestry Disability Index; 3. Rand-36; 4. EuroQol; 5. Working status; 6. MPQ-DLV. | — |
Contacts
Public ContactJosé Geurts
PO Box 5800
Outcome results
None listed