Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
06/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karolina Szadek

ORCID ID

Contact details

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

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

Sponsor information

Organisation

VU University Medical Center, Department of Anesthesiology (Netherlands)

Sponsor details

P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes