BEHANDELING VAN CHRONISCHE DISCOGENE LAGE RUGPIJN MET METHYLEEN BLAUW.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR2547
• Date of registration: 29/09/2010
• Primary sponsor: Maastricht University Medical Centre, Department of Anesthesiology and pain management
• Public title: BEHANDELING VAN CHRONISCHE DISCOGENE LAGE RUGPIJN MET METHYLEEN BLAUW.
• Scientific title: Intradiscal Methylene Blue Injection Treatment for Chronic Discogenic Low back pain. - IMBI
• Date of first enrolment: 1/4/2011
• Target sample size: 63
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2547
• Study type: intervention
• Study design: Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: J.W. Kallewaard

• Name: José Geurts

Key inclusion & exclusion 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 discography Todd Wetzel classification grade 2 and 3;

7. A provoked pain of at least NRS 5.
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;

D. Todd Wetzel classification grade 1, 4 and 5.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Low back pain (LBP), Intradiscal

Intervention(s)

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 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 NSAID?s);

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 Outcome(s)

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 Outcome(s)

1. Used analgesics;

2. Oswestry Disability Index;

3. Rand-36;

4. EuroQol;

5. Working status;

6. MPQ-DLV.

Secondary ID(s)

2010-09 / 2010-022025-15 ;

Source(s) of Monetary Support

Maastricht Universitair Medisch Centrum (MUMC+)