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…
ID
Bron
Verkorte titel
Aandoening
sacroiliac joint pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients will undergo diagnostic blockade of sacroiliac joint. Due to randomization individual will get lidocaine, lidocaine with corticosteroide or placebo.
Algemeen / deelnemers
P.O. Box 7057
Karolina Szadek
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444387
Wetenschappers
P.O. Box 7057
Karolina Szadek
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444387
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL395 |
| NTR-old | NTR435 |
| Ander register | : N/A |
| ISRCTN | ISRCTN91421011 |