Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001062617
Ethics application status
Approved
Date submitted
17/08/2014
Date registered
3/10/2014
Date last updated
12/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of the Bruce Jones Sacroiliac Technique in treatment of chronic low back pain using a prospective case series research design
Scientific title
The effect of a manual sacroiliac mobilisation technique (the Bruce Jones Sacroiliac Technique) on pain and disability in patients with chronic low back pain
Secondary ID [1] 285101 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 292653 0
Condition category
Condition code
Musculoskeletal 292966 292966 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 293469 293469 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobilisation of sacro-iliac joint via rhythmic active hip adduction from flexed position.

Treatments (maximum 30 mins) conducted weekly by osteopath with 14 years experience until subjective assessment of mobility by practitioner (usually 2 - 4 treatments).

Exact treatment duration also determined by subjective assessments of SI joint mobility made at regular intervals throughout treatment.
Intervention code [1] 289948 0
Rehabilitation
Intervention code [2] 290281 0
Treatment: Other
Comparator / control treatment
No control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292821 0
Oswestry Disability Index (ODI)
Timepoint [1] 292821 0
4 weeks after last treatment; 8 weeks after last treatment

(4 weeks primary end-point)
Primary outcome [2] 292822 0
Quadruple Visual Analog Scale (QVAS)
Timepoint [2] 292822 0
4 weeks after last treatment; 8 weeks after last treatment

(4 weeks primary end-point)
Primary outcome [3] 292823 0
Patient-Specific Functional Scale (PSFS)
Timepoint [3] 292823 0
4 weeks after last treatment; 8 weeks after last treatment

(4 weeks primary end-point)
Secondary outcome [1] 309757 0
Lumbar flexibility via inclinometer measurement for roll, pitch and yaw
Timepoint [1] 309757 0
Immediately following first treatment session only

Eligibility
Key inclusion criteria
Experienced chronic back pain longer than 6 months
Oswestry Disability Index greater than 22%
Read and understand English language
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known pathologies of lower back or spine
Recent surgery (last 6 months)
Previously had hip or knee replacement surgery
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Single cohort all received treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Single cohort all received treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
G*Power software (v3.0.1) was used to calculate the a priori sample size for a two-tailed t-test for the difference between two means. Based on an error probability of 0.05, a power (1-beta) of 0.80, the minimum required sample was 24 participants to detect an effect size of 0.6.

Changes assessed using repeated measures ANOVA for variables with more than one endpoint and dependent t-tests for measures of lumbar flexibility.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
8/08/2008
Date of last participant enrolment
Anticipated
19/12/2008
Actual
25/11/2008
Date of last data collection
Anticipated
Actual
21/01/2009
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 6270 0
New Zealand
State/province [1] 6270 0
Auckland region

Funding & Sponsors
Funding source category [1] 289707 0
University
Name [1] 289707 0
Unitec Institute of Technology
Country [1] 289707 0
New Zealand
Primary sponsor type
University
Name
Unitec Institute of Technology
Address
Private Bag 92025
Victoria Street West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 288404 0
None
Name [1] 288404 0
Address [1] 288404 0
Country [1] 288404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291447 0
Unitec Research Ethics Committee
Ethics committee address [1] 291447 0
Ethics committee country [1] 291447 0
New Zealand
Date submitted for ethics approval [1] 291447 0
02/07/2008
Approval date [1] 291447 0
23/07/2008
Ethics approval number [1] 291447 0
2008.850

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50434 0
Mr Robert W. Moran
Address 50434 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 50434 0
New Zealand
Phone 50434 0
+64 9 815 4321 ext. 8197
Fax 50434 0
Email 50434 0
[email protected]
Contact person for public queries
Name 50435 0
Robert W. Moran
Address 50435 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 50435 0
New Zealand
Phone 50435 0
+64 9 815 4321 ext. 8197
Fax 50435 0
Email 50435 0
[email protected]
Contact person for scientific queries
Name 50436 0
Robert W. Moran
Address 50436 0
Unitec Institute of Technology
Private Bag 92025
Victoria Street West
Auckland 1142
Country 50436 0
New Zealand
Phone 50436 0
+64 9 815 4321 ext. 8197
Fax 50436 0
Email 50436 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExploration of clinical changes following a novel mobilisation technique for treatment of chronic low back pain: A single cohort design.2016https://dx.doi.org/10.1016/j.jbmt.2015.12.004
N.B. These documents automatically identified may not have been verified by the study sponsor.