Diagnostic blockade of sacroiliac joint in patients with pseudoradicular low back pain
| ISRCTN | ISRCTN91421011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91421011 |
| Secondary identifying numbers | NTR435 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Karolina Szadek
Scientific
Scientific
VU University Medical Center
Department of Anesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Study information
| Study design | Randomised, double blind, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | lidocaine, methylprednisolone |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/09/2005 |
| 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 number of participants | 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
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
VU University Medical Center, Department of Anesthesiology (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
"ROR" |
https://ror.org/00q6h8f30 |
|---|
Funders
Funder type
Hospital/treatment centre
Pain Knowledge Center (cooperation funds) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
