Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000472673
Ethics application status
Approved
Date submitted
30/04/2014
Date registered
6/05/2014
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Date results information initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of physiotherapy management in pregnancy related pelvic girdle pain
Scientific title
Evaluation of physiotherapy management in pregnancy related pelvic girdle pain
Secondary ID [1] 284511 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy related pelvic girdle pain 291771 0
Condition category
Condition code
Musculoskeletal 292129 292129 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 292157 292157 0 0
Physiotherapy
Reproductive Health and Childbirth 292158 292158 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The number of interventional treatment arms is one.
1. Therapist assisted exercises. These are Muscle energy techniques for either anterior pelvic rotation or posterior pelvic rotation (as diagnosed by the physiotherapist). These are applied for 8-10secs and repeated 4-6 times within the one session.
The washout period between interventions will be 10 minutes.
Intervention code [1] 289272 0
Treatment: Other
Comparator / control treatment
Transcutaneous electrical nerve stimulation (TENS). The TENS unit will be on but will not emit any current through the electrodes which will be placed over the buttock region for 10 minutes. This is a sham treatment as it has no treatment value as there will be no output.
Control group
Placebo

Outcomes
Primary outcome [1] 292010 0
Pelvic girdle pain as assessed by visual analogue scale (VAS).
Timepoint [1] 292010 0
Immediately prior to intervention and post intervention
Primary outcome [2] 292011 0
Timed single limb stance (SLS) bilaterally.
Timepoint [2] 292011 0
Immediately prior to intervention and post intervention
Primary outcome [3] 292012 0
Timed up and go test (TUG) which is a timed test for rising uop out of a chair, walking 3 metres, turning around and then walking 3 metres back to chair and sitting down .
Timepoint [3] 292012 0
Immediately prior to intervention and post intervention
Secondary outcome [1] 307989 0
Pelvic Girdle Pain Questionnaire, which measures quality of life, activity limitations and symptoms.
Timepoint [1] 307989 0
Immediately prior to intervention and at one week post intervention.

Eligibility
Key inclusion criteria
The inclusion criteria are the report of pregnancy related pelvic girdle pain (PPGP) during two or more of the following activities: walking, standing, climbing a flight of stairs, turning over in bed or getting out of a chair. Clinical examination will confirm the diagnosis of PPGP based on positive findings on the following tests on the side of the reported symptoms: positive posterior pelvic pain provocation test (P4) and positive active straight leg raise (ASLR). Pain location will be confirmed by drawings filled in by the participant on a body chart.
Minimum age
17 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are known chronic orthopaedic, inflammatory or rheumatologial disorders, fracture, uncontrolled medical or obstetric condition and complications due to pregnancy,low back pain in past 12 months that is unrelated to the pregnancy, sensory disturbance in the lower limb on one or both sides, unilateral or bilateral lower limb weakness, pain below knee, ataxic gait, stocking like numbness, unexplained incontinence, unremitting and severe back pain not altered by different patient posture or position.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2014
Actual
12/05/2014
Date of last participant enrolment
Anticipated
Actual
3/09/2017
Date of last data collection
Anticipated
Actual
17/09/2017
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289154 0
Hospital
Name [1] 289154 0
Westmead Research Foundation
Country [1] 289154 0
Australia
Primary sponsor type
Individual
Name
Dragana Ceprnja
Address
Physiotherapy Department
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country
Australia
Secondary sponsor category [1] 287819 0
None
Name [1] 287819 0
Address [1] 287819 0
Country [1] 287819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300581 0
Westerns Sydney LHD Westmead
Ethics committee address [1] 300581 0
PO Box 533 Wentworthville NSw 2145
Ethics committee country [1] 300581 0
Australia
Date submitted for ethics approval [1] 300581 0
05/06/2013
Approval date [1] 300581 0
23/10/2013
Ethics approval number [1] 300581 0
HREC 2013/9/4.2(3803) HREC/13/Wmead/288

Summary
Brief summary
Pregnancy related pelvic girdle pain (PPGP) has been reported to affect 71% of women who are pregnant and receive care at Westmead Hospital (Pierce et al. 2012). Pelvic girdle pain during pregnancy often causes a reduced ability to transfer, stand and walk and is thought to be related to non-optimal stability of the pelvic girdle (Vleeming et al. 2008). People with PPGP are often referred to physiotherapy but few clinical trials have evaluated the effectiveness of physiotherapy treatments in this disabling condition (Elden et al. 2005).
The aim of this randomised cross-over repeated measures study is to determine whether there is a measurable difference in outcomes for pain and function in patients receiving therapist-assisted exercises compared to a control intervention. Ethical approval has been granted for this project at Westmead Hospital, Sydney NSW (Western Sydney Local Health District).
This study will directly affect physiotherapy practice by determining the efficacy of a commonly used exercise intervention for the management of PPGP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48018 0
Mrs Dragana Ceprnja
Address 48018 0
Physiotherapy Department
Westmead Hospital
PO Box 533
wentworthville NSW 2145
Country 48018 0
Australia
Phone 48018 0
+61 029845 6500
Fax 48018 0
Email 48018 0
[email protected]
Contact person for public queries
Name 48019 0
Mrs Dragana Ceprnja
Address 48019 0
Physiotherapy Department
Westmead Hospital
PO Box 533
wentworthville NSW 2145
Country 48019 0
Australia
Phone 48019 0
+610298456500
Fax 48019 0
Email 48019 0
[email protected]
Contact person for scientific queries
Name 48020 0
Mrs Dragana Ceprnja
Address 48020 0
Physiotherapy Department
Westmead Hospital
PO Box 533
wentworthville NSW 2145
Country 48020 0
Australia
Phone 48020 0
+610298456500
Fax 48020 0
Email 48020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ceprnja D, Gupta A. Does muscle energy technique ... [More Details]

Documents added automatically
No additional documents have been identified.