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Trial registered on ANZCTR


Registration number
ACTRN12605000270617
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of the Belly Bra on back pain in pregnancy
Scientific title
Evaluating the impact of the Belly Bra on back pain in pregnancy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Back pain in pregnant women 357 0
Condition category
Condition code
Reproductive Health and Childbirth 418 418 0 0
Normal pregnancy
Alternative and Complementary Medicine 419 419 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Large population studies place the prevalence of low back pain as affecting 20-49% of the low risk obstetric population (Albert et al, 2002). This study aims to evaluate, in a randomised controlled trial, whether the Belly Bra is associated with a reduction in back pain in pregnant women compared to a more generic support in the form of tubigrip. The Belly Bra, designed by Linda Turner, is alleged to provide support for the lower back and abdomen during pregnancy. Worn like a singlet, the nylon/spandex Belly Bra has a one-way stretch panel acroos the back that offers support and improves posture, whilst a wide elastic band sits below the abdomen to lift weight off the pelvis. One hundred women will be randomised, either to the intervention (Belly Bra - 50 women) or to the control (tubigrip - 50 women) by means of computer generated numbered, sealed, opaque envelopes. Each participant will be asked to complete a baseline questionnaire on enrolment and a follow-up questionnaire upon completion of their trial three weeks later.
Intervention code [1] 226 0
Treatment: Devices
Comparator / control treatment
Control (tubigrip)
Control group
Placebo

Outcomes
Primary outcome [1] 480 0
The primary hypothesis is that the use of the Belly Bra will be associated with changes in Visual Analogue Scale (VAS) assessments of pain intensity scores compared with the control (Tubigrip).
Timepoint [1] 480 0
Measured three weeks after commencing usage
Primary outcome [2] 481 0
The primary hypothesis is that the use of the Belly Bra will be associated with changes in Visual Analogue Scale (VAS) assessments of changes in physical activity scores compared with the control (Tubigrip).
Timepoint [2] 481 0
Measured three weeks after commencing usage
Secondary outcome [1] 1037 0
Use of analgesic medication
Timepoint [1] 1037 0
Measured three weeks after commencing usage.
Secondary outcome [2] 1038 0
Need for additional treatment (such as physiotherapy, acupuncture of pelvic support girdles)
Timepoint [2] 1038 0
Measured three weeks after commencing usage.

Eligibility
Key inclusion criteria
Obstetric patients in the second half of pregnancy presenting at the antenatal clinic of The Royal Women's Hospital or Mercy Hospital with low back pain (including pelvic girdle syndrome, one-sided sacroiliac syndrome or two-sided sacroiliac syndrome) will be invited to participate in this trial.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women with symphysiolysis (anterior pelvic pain).

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)
sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated numbered envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 472 0
Commercial sector/Industry
Name [1] 472 0
Belly Bra Company
Country [1] 472 0
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
Country
Australia
Secondary sponsor category [1] 379 0
Hospital
Name [1] 379 0
The Royal Women's Hospital
Address [1] 379 0
Country [1] 379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1445 0
The Royal Women's Hospital
Ethics committee address [1] 1445 0
Ethics committee country [1] 1445 0
Australia
Date submitted for ethics approval [1] 1445 0
Approval date [1] 1445 0
Ethics approval number [1] 1445 0
Ethics committee name [2] 1446 0
The Mercy Hospital for Women
Ethics committee address [2] 1446 0
Ethics committee country [2] 1446 0
Australia
Date submitted for ethics approval [2] 1446 0
Approval date [2] 1446 0
Ethics approval number [2] 1446 0

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

Contacts
Principal investigator
Name 36307 0
Address 36307 0
Country 36307 0
Phone 36307 0
Fax 36307 0
Email 36307 0
Contact person for public queries
Name 9415 0
Dr Louise Kornman
Address 9415 0
Department of Obstetrics and Gynaecology
University of Melbourne
The Royal Women's Hospital
132 Grattan Street
Carlton VIC 3053
Country 9415 0
Australia
Phone 9415 0
+61 3 93442130
Fax 9415 0
Email 9415 0
[email protected]
Contact person for scientific queries
Name 343 0
A/Professor Julie Quinlivan
Address 343 0
Department of Obstetrics and Gynaecology
University of Melbourne
The Royal Women's Hospital
132 Grattan Street
Carlton VIC 3053
Country 343 0
Australia
Phone 343 0
+61 3 93442130
Fax 343 0
Email 343 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
No additional documents have been identified.