Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000898651
Ethics application status
Approved
Date submitted
13/08/2014
Date registered
25/08/2014
Date last updated
25/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The evaluation of two types of pelvic support belt commonly used in the treatment of pubic symphysis pain to assess their comfort and symptom relief in pregnant New Zealand women; a pilot study.
Scientific title
The evaluation of two types of pelvic support belt commonly used in the treatment of pubic symphysis pain to assess their comfort and symptom relief in pregnant New Zealand women; a pilot study.
Secondary ID [1] 285142 0
Nil known
Universal Trial Number (UTN)
U1111-1160-2806
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pubic symphysis pain 292726 0
Pregnancy 292727 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293023 293023 0 0
Physiotherapy
Musculoskeletal 293094 293094 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 293095 293095 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three weeks wear of a wide, flexible neoprene support belt. Participants were shown by a physiotherapist how to wear the belt, aligned over the pubic symphysis and were advised to wear it whenever possible during waking hours. Women were sent daily text messages asking whether pain and function had improved (yes/no/sometimes) and for how many hours they wore the belt for. Weekly phone interviews also monitored adherence, comfort and pain and functional improvement.
Intervention code [1] 289992 0
Treatment: Devices
Comparator / control treatment
Three weeks wear of a thinner, more rigid pelvic support belt made of cotton webbing with foam lining. Participants were shown by a physiotherapist how to wear the belt, aligned over the pubic symphysis and were advised to wear it whenever possible during waking hours. Women were sent daily text messages asking whether pain and function had improved (yes/no/sometimes) and for how many hours they wore the belt for. Weekly phone interviews also monitored adherence, comfort and pain and functional improvement.
Control group
Active

Outcomes
Primary outcome [1] 292884 0
Patient Specific Functional Scale. Administered verbally and completed by the study investigator. Each participant was required to identify three important activities, and up to two additional activities, that they were unable to do or have difficulty with as a result of their problem (pubic symphysis pain). Then, on a scale of 0 to 10, with 0 being unable to perform the activity and 10 able to perform the activity at pre-pregnancy level, participants rated their ability to perform each activity that was identified.
Timepoint [1] 292884 0
Three weeks
Secondary outcome [1] 309872 0
Pain intensity rated on the 10cm Visual Analogue Scale for worst pain over the preceding 24 hours. Participants were asked to mark an X on the 10cm line provided to represent their worst pubic symphysis pain experienced during the last 24 hour period. A mark on the left hand side of the scale (at 0cm) indicated participants experienced "no pain", and at a mark on the right hand side of the scale (at 10cm) indicated that participants experienced "worst possible pain".
Timepoint [1] 309872 0
Three weeks
Secondary outcome [2] 309873 0
Pain intensity rated on the 10cm Visual Analogue Scale for the worst pain over the preceding week. Participants were asked to mark an X on the 10cm line provided to represent their worst pubic symphysis pain experienced during the last week. A mark on the left hand side of the scale (at 0cm) indicated participants experienced "no pain", and at a mark on the right hand side of the scale (at 10cm) indicated that participants experienced "worst possible pain".
Timepoint [2] 309873 0
Three weeks
Secondary outcome [3] 309874 0
Functional status determined by the Modified Oswestry Disability Questionnaire. Participants self completed the questionnaire which asks about pain intensity, ability to maintain personal care, ability to perform tasks such as lifting, walking, sitting, standing, sleeping and driving, and the impact of their pain on their social lives, employment/homemaking and sex lives. Participants were asked to tick one box for each category that best described their condition on the day they were completing the questionnaire.
Timepoint [3] 309874 0
Three weeks

Eligibility
Key inclusion criteria
Pregnant women, at least 18 years of age, whom had experienced pubic symphyseal pain for at least two weeks (which was worse than any concurrent posterior pelvic pain), and had a positive response to at least two of three clinical tests: reproduction of pain from palpation, modified Trendelenburg's test, active straight leg raise test.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with a known high-risk pregnancy, a history of major systemic bone disease and/or back or pelvic injury, a medical condition which contraindicated the use of a pelvic support belt (e.g. certain types of placenta previa), or those currently taking steroid medication

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)
One of the study designers, who was not involved in participant recruitment, assessment or data collection, performed the randomization of participants and concealed the results in sealed opaque envelopes, sequentially numbered. Following assessment and enrollment into the study, the study administrator drew and opened the next sequentially numbered envelope and then communicated with the assessor (physiotherapist) about which belt each participant would be using.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Performed by one of the study designers not involved in assessment or data collection. Using a computer-generated random number table and block sizes of 4, participants were assigned in a 1:1 allocation to either flexible or rigid belt.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Before a multi-center trial of pelvic support belts can be launched, it is essential to gather data on the most appropriate type of belt, symptomatic effectiveness, comfort, and adherence as well as to provide estimates of anticipated variability and correlations between repeated measures. Having 10 participants in each arm of this study was considered sufficient to obtain preliminary data to help with estimating power for a larger subsequent study. Data were entered into a spreadsheet. Any out of range values were double-checked for input accuracy. Appropriate descriptive statistics were derived for all variables. Linear regression models were used to examine differences in follow-up values between the two groups (flexible and rigid belts) after adjusting for baseline values. Model assumptions were assessed using histograms of residuals, plots of residuals against fitted values, and Levene’s test for equality of variance between groups. Where model residuals were positively skewed or demonstrated heteroscedasticity, natural logarithmic transformations were investigated, after adding one in the case of measures that included zero values. Overall changes (across both groups) in measures were examined using paired t-tests where there was no evidence of differences in change between groups and regression models using follow-up values while controlling for baseline values were used to assess any association with compliance. Stata 13.1 was used for all statistical analysis and all tests were performed using two-sided p < 0.05 as indicating statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/07/2011
Actual
12/07/2011
Date of last participant enrolment
Anticipated
1/05/2012
Actual
1/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 6289 0
New Zealand
State/province [1] 6289 0
Dunedin, Otago

Funding & Sponsors
Funding source category [1] 289750 0
University
Name [1] 289750 0
University of Otago Research Grant (UORG)
Country [1] 289750 0
New Zealand
Primary sponsor type
Individual
Name
Stephanie Woodley
Address
Department of Anatomy
University of Otago
Lindoferguson Building
270 Great King Street
Dunedin 9016

PO Box 913
Dunedin 9054

New Zealand
Country
New Zealand
Secondary sponsor category [1] 288442 0
Individual
Name [1] 288442 0
Natasha Flack
Address [1] 288442 0
Department of Anatomy
University of Otago
Lindoferguson Building
270 Great King Street
Dunedin 9016

PO Box 913
Dunedin 9054

New Zealand
Country [1] 288442 0
New Zealand
Secondary sponsor category [2] 288454 0
Individual
Name [2] 288454 0
Jean Hay-Smith
Address [2] 288454 0
Department of Medicine
University of Otago
Wellington
PO Box 7343
Wellington South 6242

New Zealand
Country [2] 288454 0
New Zealand
Secondary sponsor category [3] 288455 0
Individual
Name [3] 288455 0
Mark Stringer
Address [3] 288455 0
Department of Anatomy
School of Medical Sciences
University of Otago
PO Box 913
Dunedin 9054

New Zealand
Country [3] 288455 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291483 0
New Zealand Upper South A Regional Ethics Committee
Ethics committee address [1] 291483 0
c/- Ministry of Health
Montogmery Watson Building
6 Hazeldean Road
Christchurch 8024
Ethics committee country [1] 291483 0
New Zealand
Date submitted for ethics approval [1] 291483 0
21/04/2011
Approval date [1] 291483 0
13/06/2011
Ethics approval number [1] 291483 0
URA/11/05/012

Summary
Brief summary
The pubic symphysis is a joint at the front of the pelvis that can cause pain during pregnancy and after delivery. This pain is not well understood. In particular, how common it is and how it changes during and after pregnancy are poorly described. The effectiveness of suggested treatments are unknown. This pilot study aimed to trial two types of pelvic belt commonly used in the treatment of symphyseal pain to assess their comfort and symptom relief.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50606 0
Dr Stephanie Woodley
Address 50606 0
Department of Anatomy
University of Otago
Lindo Ferguson Building
270 Great King St
Dunedin 9016

PO Box 913
Dunedin 9054

New Zealand
Country 50606 0
New Zealand
Phone 50606 0
+6434797353
Fax 50606 0
Email 50606 0
stephanie.woodley@anatomy.otago.ac.nz
Contact person for public queries
Name 50607 0
Stephanie Woodley
Address 50607 0
Department of Anatomy
University of Otago
Lindo Ferguson Building
270 Great King St
Dunedin 9016

PO Box 913
Dunedin 9054

New Zealand
Country 50607 0
New Zealand
Phone 50607 0
+6434797353
Fax 50607 0
Email 50607 0
stephanie.woodley@anatomy.otago.ac.nz
Contact person for scientific queries
Name 50608 0
Natasha Flack
Address 50608 0
Department of Anatomy
University of Otago
Lindo Ferguson Building
270 Great King St
Dunedin 9016

PO Box 913
Dunedin 9054

New Zealand
Country 50608 0
New Zealand
Phone 50608 0
+6434795992
Fax 50608 0
Email 50608 0
natasha.flack@anatomy.otago.ac.nz

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
EmbaseAdherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - A pilot randomized trial.2015https://dx.doi.org/10.1186/s12884-015-0468-5
N.B. These documents automatically identified may not have been verified by the study sponsor.