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

VU University Medical Center
Department of Anesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Study information

Study designRandomised, double blind, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymSI diagnostic blockade
Study objectives1. 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) studiedSacroiliac joint pain
InterventionPatients will undergo diagnostic blockade of sacroiliac joint. Due to randomization individual will get lidocaine, lidocaine with corticosteroid or placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)lidocaine, methylprednisolone
Primary outcome measureThe 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 measuresWith 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 date01/09/2005
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexNot Specified
Target number of participants63
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2005
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center, Department of Anesthesiology (Netherlands)
Hospital/treatment centre

P.O. Box 7057
Amsterdam
1007 MB
Netherlands

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan