search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Diagnostic blockade of sacroiliac joint in patients with pseudoradicular low back pain.


- candidate number1717
- NTR NumberNTR435
- ISRCTNISRCTN91421011
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR21-sep-2005
- Secondary IDsN/A 
- Public TitleDiagnostic blockade of sacroiliac joint in patients with pseudoradicular low back pain.
- Scientific TitleDiagnostic blockade of sacroiliac joint in patients with pseudoradicular low back pain. Randomized, double blind study.
- ACRONYMSI diagnostic blockade
- hypothesis1. In patients with non-specific low back pain, 10 ml lidocaine 2% reduce the pain more then 2 cm at the BOX-score compare to the placebo group;
2. In patients with non-specific low back pain, 9 ml lidocaine 2% with 1 ml corticosteroid (40 mg methylprednisolone) reduce pain more then 2 cm at the BOX-score compare to the placebo group;
3. In patients with non-specific low back pain, 9 ml lidocaine 2% with 1 ml corticosteroid (40 mg methylprednisolone) reduce pain more then 2 cm at the BOX-score compare to the lidocaine group.
- Healt Condition(s) or Problem(s) studiedSacroiliac joint pain
- Inclusion criteria1. Pseudoradicular character of pain;
2. Pain below L5;
3. Pain localized above sulcus sacralis;
4. Unilateral pain;
5. Age 18- 70;
6. Three or more positive provocation tests for sacroiliac joint pain;
7. Patient has to speak Dutch;
8. Informed consent is required.
- Exclusion criteria1. Allergy to iodine, lidocaine or cortocosteroide;
2. Pregnancy;
3. General contraindications for invasive treatment;
4. Appearance of a specific cause of low back pain (red flags);
5. Participation in another study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-sep-2007
- Target number of participants63
- InterventionsPatients will undergo diagnostic blockade of sacroiliac joint. Due to randomization individual will get lidocaine, lidocaine with corticosteroide or placebo.
- Primary outcomeThe effect of the diagnostic blockade is evaluated through a 10 items BOX-score (box 1 represents no pain, box 10 represents the worst imaginable pain). Patients will fill the BOX-score (diary) in at home 3 times a day, during at least 4 weeks after a blockade.
- Secondary outcomeWith the Roland Disability questionnaire and Oswestry Low Back Pain Disability Index the limitation caused by low back pain will be assessed. Global health will be assessed using the short form (SF)-36 and COOP-Wonca questionnaire. Additionally the duration of a pain free period and daily pain medication use will be reviewed.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD. Karolina Szadek
- CONTACT for SCIENTIFIC QUERIESPhD. Karolina Szadek
- Sponsor/Initiator VU University Medical Center, Department of Anesthesiology
- Funding
(Source(s) of Monetary or Material Support)
Pain Knowledge Center cooperation funds
- PublicationsN/A
- Brief summaryObjective:
To compare the efficacy of diagnostic blockade with lidocaine or lidoca´ne with methylprednisolone to placebo in reducing the pain in patients with sacroiliac joint pain. In all patients a single blockade of a sacroiliac joint will be performed. The individual patient will be included at random to one of three trial groups:
1) group which will receive an injection of 10ml lidocaine,
2) group which will receive an injection of 9ml lidocaine with 40 mg mathylprednisolone,
3) 10ml of 0,9% NaCl in a placebo group. All the injections will be performed under a fluoroscopic guidance. The good position of the injection needle in the sacroiliac joint will be confirmed with contrast material. Afterwards three x-ray photos of the sacroiliac joint in three dimensions will be taken. Outcome will be assessed during 4 weeks after the intervention with BOX-score as a primary outcome. Secondary outcomes concern to Roland Disability questionnaire, Oswestry Low Back Pain Disability Index, COOP-Wonca questionnaire and SF-36, the duration of a pain free period and additionally a daily pain medication use. The outcome will be compared with a baseline, one week prior an injection. The follow up will be carried out for maximum 3 month after the injection.
- Main changes (audit trail)
- RECORD21-sep-2005 - 5-jan-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl