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Trial registered on ANZCTR


Registration number
ACTRN12610000823077
Ethics application status
Approved
Date submitted
19/09/2010
Date registered
1/10/2010
Date last updated
1/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel approaches to improve pain and function in those with sacro-iliac joint dysfunction
Scientific title
Prolotherapy versus placebo injections to improve pain and function in patients with form failure of load transfer of the sacroiliac joint
Secondary ID [1] 252715 0
Nil
Universal Trial Number (UTN)
U1111-1117-1011
Trial acronym
prolosij
Linked study record

Health condition
Health condition(s) or problem(s) studied:
failure of form closure of the sacro-iliac joint 258205 0
Condition category
Condition code
Musculoskeletal 258385 258385 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Injection of 1.0ml of 20% Dextrose in 0.5% Bupivicaine in the dorsal interosseous ligament of the Sacro-Iliac Joint (SIJ)versus placebo needle. Maximum of six injections. A previous observational trial with three injections (same protocol) yielded good results (Cusi et al, BJSM 2010). The total six injections maximum corresponds to three placebo injections and the cross over three Dextrose injections. Injections are every six weeks. Unblinding after the third injection. If the patient has made adequate improvement no further injections may be required. Six weeks after the third injection unblinding takes place, and cross over takes place at that time.
Intervention code [1] 257222 0
Treatment: Other
Intervention code [2] 257227 0
Treatment: Drugs
Comparator / control treatment
Placebo dry needle in a more superficial plane, without reaching the posterior interosseous ligament of the sacro-iliac joint
Control group
Placebo

Outcomes
Primary outcome [1] 259227 0
clinical assessment: Active straight leg raise, palpation of long dorsal sacro-iliac ligament, Stork test and posterior pelvic pain provocation test
Timepoint [1] 259227 0
Three months post final injection
Primary outcome [2] 259228 0
Pain. Visual Analogue Scale
Timepoint [2] 259228 0
Three months post final injection
Primary outcome [3] 259229 0
Functional questionnaires: Quebec Disability Index, Roland Morris 24 and Roland Morris 24 multi,
Timepoint [3] 259229 0
Three months post final injection
Secondary outcome [1] 265634 0
Patient perception of function. Patient Generated Index
Timepoint [1] 265634 0
three months post post final injection

Eligibility
Key inclusion criteria
Failure of load transfer not improved with specific lumbopelvic stability exercises
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infection, fracture, cancer, psychiatric disorders, pregnancy, previous prolotherapy in the same SIJ

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients who fulfil the criteria for diagnosis of failure of load transfer through the sacroiliac joint -history, clinical examination and Single Photon Emission Computerised Tomography - Computed X-ray Tomography (SPECT-CT)- will be asked to participate in this randomised double blind crossover trial. Allocation is concealed by sealed opaque envelopes held by the radiologist who carries out the injections, in a different site to where patients are assessed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator where an odd number is placebo and an even number prolotherapy injection. Allocation concealment to be done with sealed envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257670 0
Self funded/Unfunded
Name [1] 257670 0
Dr Manuel (Mel) Cusi
Address [1] 257670 0
160 Belmore Road
Randwick NSW 2031
Country [1] 257670 0
Australia
Primary sponsor type
Individual
Name
Dr Manuel (Mel) Cusi
Address
15 Vernon Street
Strathfield NSW 2135
Country
Australia
Secondary sponsor category [1] 256886 0
Individual
Name [1] 256886 0
Dr Hans van der Wall
Address [1] 256886 0
4 Hospital Road
Concord West NSW 2138
Country [1] 256886 0
Australia
Other collaborator category [1] 251502 0
Individual
Name [1] 251502 0
Dr Louise Wong
Address [1] 251502 0
4 Hospital Road
Concord West NSW 2138
Country [1] 251502 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259695 0
University of Notre Dame Australia, Sydney Medical School
Ethics committee address [1] 259695 0
160 Oxford Street
Darlinghurst NSW 2010
Ethics committee country [1] 259695 0
Australia
Date submitted for ethics approval [1] 259695 0
Approval date [1] 259695 0
03/07/2008
Ethics approval number [1] 259695 0
Ethics committee name [2] 259697 0
Australian Institute of Sports Ethics Committee
Ethics committee address [2] 259697 0
Australian INstitute of Sport
PO Box 176
Belconnen ACT 2616
Ethics committee country [2] 259697 0
Australia
Date submitted for ethics approval [2] 259697 0
Approval date [2] 259697 0
02/02/2010
Ethics approval number [2] 259697 0
20091007

Summary
Brief summary
Patients with low back pain who fulfil the diagnostic criteria for deficient load transfer through the sacro-iliac joint (SIJ) (Hungerford et al, 2004; Mens et al, 2001) (sacro-iliac joint dysfunction) and who do not respond to exercise therapy have deficient ligamentous function.
1. The primary hypothesis of this study is that the injection of 20% Glucose solution into the posterior ligaments of the SIJ will stimulate the formation of new collagen and increase ligament strength. Tis will be measured by improvement in the following tests:
a) Stork test (Hungerford et al Spine 2004),
b) Active straight leg raise (ASLR) (Mens et al, 2001 and 2002) ,
c) Posterior pelvic pain provocation test (PPPP) (Ostgaard et al, 1994, Vleeming et al, 2002)
d) Palpation of the long dorsal sacro-iliac ligament (Vleeming at al, 1996)
2. The secondary hypothesis is that the improvement in the ligament function will lead to a decrease in symptoms and an improvement in quality of life measured by
a) Quebec Back Pain Disability Scale (Kopek et al, 1995) and
b) Patient Generated Index Questionnaire (PGI) Ruta at al, 1994 Both have been used previously in back pain studies.
The aim of the study is to compare by randomised trial wether CT guided injection of 20% glucose solution into the ligaments of the sacroiliac joint as compared to a sham injection control results in
a) A negative Stork test
b) A negative ASLR test
c) A negative PPPP test
d) A lower Quebec score
e) Improvement in the PGI, as measured three months after the intervention
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31656 0
Address 31656 0
Country 31656 0
Phone 31656 0
Fax 31656 0
Email 31656 0
Contact person for public queries
Name 14903 0
Dr Manuel (Mel) Cusi
Address 14903 0
160 Belmore Road
Randwick NSW 2031
Country 14903 0
Australia
Phone 14903 0
61-2-9399 5333
Fax 14903 0
Email 14903 0
m.cusi@unsw.edu.au
Contact person for scientific queries
Name 5831 0
Dr Manuel (Mel) Cusi
Address 5831 0
160 Belmore Road
Randwick NSW 2031
Country 5831 0
Australia
Phone 5831 0
61-2-93995333
Fax 5831 0
Email 5831 0
m.cusi@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results