Diagnostic blockade of sacroiliac joint in patients with pseudoradicular low back pain
| ISRCTN | ISRCTN91421011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91421011 |
| Protocol serial number | NTR435 |
| Sponsor | VU University Medical Center, Department of Anesthesiology (Netherlands) |
| Funder | Pain Knowledge Center (cooperation funds) (Netherlands) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 06/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
VU University Medical Center
Department of Anesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SI diagnostic blockade |
| Study objectives | 1. In patients with non-specific low back pain, 10 ml lidocaine 2% reduces the pain more than 2 cm at the BOX-score compared to the placebo group 2. In patients with non-specific low back pain, 9 ml lidocaine 2% with 1 ml corticosteroid (40 mg methylprednisolone) reduces pain more than 2 cm at the BOX-score compared to the placebo group 3. In patients with non-specific low back pain, 9 ml lidocaine 2% with 1 ml corticosteroid (40 mg methylprednisolone) reduces pain more than 2 cm at the BOX-score compared to the lidocaine group |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Sacroiliac joint pain |
| Intervention | Patients will undergo diagnostic blockade of sacroiliac joint. Due to randomization individual will get lidocaine, lidocaine with corticosteroid or placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | lidocaine, methylprednisolone |
| Primary outcome measure(s) |
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, for at least 4 weeks after a blockade. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Not Specified |
| Target sample size at registration | 63 |
| Key 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 |
| Key exclusion criteria | 1. Allergy to iodine, lidocaine or corticosteroid 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
