Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR435
Study information
Scientific title
Acronym
SI diagnostic blockade
Study hypothesis
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
Received from local medical ethics committee
Study design
Randomised, double blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
lidocaine, methylprednisolone
Primary outcome measures
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 trial start date
01/09/2005
Overall trial end date
01/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
63
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
01/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Pain Knowledge Center (cooperation funds) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary