No registrations found.
ID
Source
Brief title
Health condition
sacroiliac joint pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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 outcome
With 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.
Background summary
Objective:
To compare the efficacy of diagnostic blockade with lidocaine or lidocaïne 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.
Study objective
1. 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.
Study design
N/A
Intervention
Patients will undergo diagnostic blockade of sacroiliac joint. Due to randomization individual will get lidocaine, lidocaine with corticosteroide or placebo.
P.O. Box 7057
Karolina Szadek
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444387
P.O. Box 7057
Karolina Szadek
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444387
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL395 |
| NTR-old | NTR435 |
| Other | : N/A |
| ISRCTN | ISRCTN91421011 |