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Trial registered on ANZCTR


Registration number
ACTRN12615000884505
Ethics application status
Approved
Date submitted
3/07/2015
Date registered
24/08/2015
Date last updated
24/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of the effects of the SacroFix Brace (SB) on pain, disability and emotional state in patients with pelvic girdle pain (SB2014).
Scientific title
A pilot study of the effects of the SacroFix Brace (SB) on pain, disability and emotional state in patients with pelvic girdle pain (SB2014).
Secondary ID [1] 286864 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic girdle pain 295261 0
Condition category
Condition code
Musculoskeletal 295506 295506 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 295507 295507 0 0
Other reproductive health and childbirth disorders
Physical Medicine / Rehabilitation 295873 295873 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six week observation of patients fitted with the SacroFix Brace for management of pelvic girdle pain (PGP).

SacroFix compression shorts provide a general supportive compression to the whole of the pelvic girdle whilst producing targeted compression to either the Sacroiliac joints or the Symphysis pubis.

Duration of use is a minimum of 4 hours per day, but not during the night. The total duration of the intervention is 6 weeks. Participants will be required to record device usage in a daily diary which will be returned to the clinic upon completion of the study.

Participants will attend the clinic for fitting of the brace, estimated to take approximately 45 minutes.
Intervention code [1] 292253 0
Treatment: Devices
Comparator / control treatment
No control group is used for this pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295482 0
Pain as assessed by numerical rating scale (NRS)
Timepoint [1] 295482 0
Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The primary endpoint assessments will take place at the 3 week timepoint.
Primary outcome [2] 295553 0
Disability as assessed by Oswestry Disability Index (ODI)
Timepoint [2] 295553 0
Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The primary endpoint assessments will take place at the 3 week timepoint.
Primary outcome [3] 295554 0
Emotional state as assessed by Depression, Anxiety and Stress Scale 41 (DASS41)
Timepoint [3] 295554 0
Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The primary endpoint assessments will take place at the 3 week timepoint.
Secondary outcome [1] 315672 0
Pain as assessed by numerical rating scale (NRS)
Timepoint [1] 315672 0
Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The secondary endpoint assessments will take place at the 6 week timepoint.
Secondary outcome [2] 316808 0
Disability as assessed by Oswestry Disability Index (ODI)
Timepoint [2] 316808 0
Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The secondary endpoint assessments will take place at the 6 week timepoint.
Secondary outcome [3] 316809 0
Emotional state as assessed by Depression, Anxiety and Stress Scale 41 (DASS41)
Timepoint [3] 316809 0
Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The secondary endpoint assessments will take place at the 6 week timepoint.

Eligibility
Key inclusion criteria
-PGP equal to or grater than 4/10 on NRS
-Increased pain or effort on ASLR test
-Pain reduced with compression of the pelvis
-Pain on one side of the posterior pelvis +/- pubis region
-Male or Female
-Age 18 to 40 years
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients with pain increased with compression of the pelvis
-Participants below 18 years of age and above 40 years
-Pregnant women in 3rd trimester of pregnancy
-Inflammatory arthritis
-Unable to self fit the shorts
-Unable to read/understand English
- Known allergy to either Lycra and/or Meryl material

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 291595 0
Commercial sector/Industry
Name [1] 291595 0
SpineCorporation Ltd
Country [1] 291595 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
SpineCorporation Ltd
Address
Millennium House
Peak Business Park
Foxwood Road
Chesterfield S41 9RF
Derbyshire, United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 290267 0
Individual
Name [1] 290267 0
Dr. Bruce Mitchell
Address [1] 290267 0
Metro Pain Group
Level 1 544 Hawthorn Road,
Caulfield South Victoria 3162
Country [1] 290267 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293126 0
Bellberry Ltd
Ethics committee address [1] 293126 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 293126 0
Australia
Date submitted for ethics approval [1] 293126 0
01/05/2015
Approval date [1] 293126 0
22/07/2015
Ethics approval number [1] 293126 0
2014-12-690

Summary
Brief summary
Sacroiliac Joint Dysfunction (SIJD) and Pregnancy Related Pelvic Girdle Pain (PRPGP) can be grouped together under the heading of ‘Pelvic Girdle Pain’ (PGP) which makes up part of the generic ‘Low Back Pain’ (LBP) group. As a main pain source it is reported to account for between 10% and 30% of all nonspecific LBP. The cost to an industrialized country, from PGP, is significant (USA alone in the region of $10 to $60 billion a year).

Treatment for SIJD and PRPGP tends to encompass either/and pain relieving modalities (acupuncture, pain medication, use of pillows and belts) and exercise. The overall evidence on the outcome of these modalities is poor.

The use of pelvic belts has developed from biomechanical studies that have shown that the external forces from a belt can help increase the ‘force closure’ of the pelvis. Another important aspect is the position of the belt with greater stability being produced on the pelvis with the belts being positioned higher, just below the anterior superior iliac crests, as opposed to the symphysis pubis.

The product being investigated is the SpineCor SI Brace (SSIB). The SSIB consists of a unique design of compressive shorts with an integrated belt that allows a variable amount and direction of compression to be applied to the pelvic girdle. It was felt that a more comfortable and biomechanically effective design could help this patient group.

The hypothesis of this study is that the use of the SacroFix brace will result in a reduction in pain and disability and an improvement in the emotional state of patients suffering with pelvic girdle pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57846 0
Dr Bruce Mitchell
Address 57846 0
Metro Pain Group Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 57846 0
Australia
Phone 57846 0
+61 3 9595 6111
Fax 57846 0
Email 57846 0
[email protected]
Contact person for public queries
Name 57847 0
Adele Barnard
Address 57847 0
Metro Pain Group Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 57847 0
Australia
Phone 57847 0
+61 3 9595 6111
Fax 57847 0
Email 57847 0
[email protected]
Contact person for scientific queries
Name 57848 0
Adele Barnard
Address 57848 0
Metro Pain Group Level 1 544 Hawthorn Road, Caulfield South Victoria 3162
Country 57848 0
Australia
Phone 57848 0
+61 3 9595 6111
Fax 57848 0
Email 57848 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

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