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Trial registered on ANZCTR


Registration number
ACTRN12619001604190p
Ethics application status
Not yet submitted
Date submitted
24/10/2019
Date registered
21/11/2019
Date last updated
21/11/2019
Date data sharing statement initially provided
21/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pregnancy-related pelvic girdle pain and massage
Scientific title
The effectiveness of massage in treating pregnant women with pelvic girdle pain: a randomised-controlled crossover feasibility study
Secondary ID [1] 299638 0
Nil known
Universal Trial Number (UTN)
U1111-1242-5288
Trial acronym
PPGPFS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy-related pelvic girdle pain 314957 0
Condition category
Condition code
Musculoskeletal 313301 313301 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 313302 313302 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 313540 313540 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remedial Pregnancy Massage Arm. Treatment will consist of remedial massage techniques specifically for pregnant women to the pelvis with the addition of treatment to the lumbar spine or adductors depending on presentation.
All participants will receive 2 x 60-minute massage treatments Treatments will be spaced between 7 and 11 days apart.
CI Fogarty, a qualified massage therapist, will be administering the massage.
A treatment form will be completed to describe the treatment received and to log treatemnts.
The washout period between treatments is 11-14 days.
Intervention code [1] 315898 0
Treatment: Other
Comparator / control treatment
Exercise Arm: Treatment will consist of exercises designed by a physiotherapist with expertise in treating pregnant women with pelvic girdle pain. Exercises will target the deep and superficial lumbopelvic muscles, pelvic floor and transverse abdominis to help manage and reduce pregnancy-related pelvic girdle pain.
All participants will receive 2 x 60 minute exercise treatments. Treatments will be spaced between 7 and 11 days apart. The wash out period will be 11-14 days.
Control group
Active

Outcomes
Primary outcome [1] 321782 0
Feasibility - recruitment and retention rates
• Recruitment – Information will be collected about where participants are recruited from to determine future advertising strategies. Information will be collected on the reason and number of people excluded from the study to determine inclusion/exclusion criteria for future studies. (Information gathered on the PPGP Study Participant Requirement Form).
• Retention – Information will be collected on the reasons for participant drop out to determine any potential issues with participant retention.
Timepoint [1] 321782 0
This information will be collected during the recruitment and enrolment stage of the study plus post study completion (participant retention).
Primary outcome [2] 321990 0
Feasibility - crossover study design methodology
Statistical analysis will determine any period or carry over effects and the information used to guide future wash out periods and study design. Data used in the crossover analysis will include the self-administered outcome measures: pain perception on a pain intensity-numeric rating scale (PINR) (pre and post treatment and 1-week post final treatment), function (The Pelvic Girdle Questionnaire) (pre treatments and 1-week post final treatment), quality of life (The Short Form Health Survey (SF-36) (25) (pre treatments and 1-week post final treatment).
Timepoint [2] 321990 0
Analysis stage of the trial.
Primary outcome [3] 321991 0
Feasibility - participant sub-characteristics
Participants sub characteristics – The presentation of PPGP can differ between participants and this will be investigated via the following participant sub characteristics:
• Number of sites of pelvic girdle (1-2 sites of pain versus three or more sites)
• Positive pain reproduction testing versus negative pain reproduction testing
• Those with PPGP and lumbar pain versus PPGP and no lumbar pain
Timepoint [3] 321991 0
Analysis stage of the trial from data collected at each treatment (Client History and Examination forms)
Secondary outcome [1] 376186 0
The acceptability of the outcome measures including pain, disability and quality of life. This is a composite outcome assessed via a post intervention questionnaire (designed by the researchers involving qualitative/quantitative questions such as such as ‘did the study questionnaires capture the symptoms and impact the PPGP had on you physically, emotionally and psychologically?).
Timepoint [1] 376186 0
1-week post final treatment of each arm.
Secondary outcome [2] 376933 0
Patient satisfaction will be measured using the Patient Satisfaction Questionnaire Short-Form (PSQ-18) (1-week post final treatment).
Timepoint [2] 376933 0
1-week post final treatment of each arm.

Eligibility
Key inclusion criteria
Women 18 years of age or greater, between 13 and 30 weeks of pregnancy (i.e. able to get on and off the floor/massage table). Participants with both low back pain and pregnancy-realted pelvic girdle pain (PPGP) will be included in the study. Participants will be eligible if they have sought treatment for their PPGP prior to enrolling in the study but will need to cease physiotherapy, massage, osteopathic, and/or chiropractic treatment while participating in the study.
Minimum age
18 Years
Maximum age
60 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with serious pathological low back pain such as Cauda Equina Syndrome, rheumatic diseases, osteomyelitis, neoplastic disease, and osteoporosis will be excluded. A letter will be sent to all obstetric health care providers advising them that the participant is taking place in the study; not consenting to this letter being sent will lead to exclusion. Pre-existing conditions that are well managed under the care of a GP or obstetrician will not lead to exclusion. Multiparity is not an exclusion criterion unless there is compromised health. Participants will be excluded if they receive any manual therapy such as physiotherapy, osteopathy, chiropractic, or non-study massage treatment for their PPGP during their time in the study.

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)
Allocation will be made by an independent researcher at WSU and advised directly to the therapist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher based at Western Sydney University (WSU) will prepare the randomisation schedule, which will be computer generated using an online service (sealedenvelope.com).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size for a feasibility studies is determined by ensuring enough study participants to adequately test the feasibility and by budgetary costs. The study will aim to recruit 24 pregnant women in total.
Demographic data will be summarised using summary statistics (for continuous variables (e.g. mean ± SD for age) and categorical variables (e.g. count/percentage for previous pregnancy massage experience). A t-test will be used to determine carry over and period effects and to compare baseline and post treatment scores for patient sub characteristics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28325 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [2] 28326 0
3166 - Oakleigh

Funding & Sponsors
Funding source category [1] 304113 0
Commercial sector/Industry
Name [1] 304113 0
Pregnancy Massage Australia
Address [1] 304113 0
Pregnancy Massage Australia
PO Box 86
Bright Vic 3741
Phone 1300 773462
Country [1] 304113 0
Australia
Funding source category [2] 304114 0
University
Name [2] 304114 0
Western Sydney University
Address [2] 304114 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country [2] 304114 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 304328 0
None
Name [1] 304328 0
None
Address [1] 304328 0
None
Country [1] 304328 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304601 0
Western Sydney Human Rsearch Ethics Committee
Ethics committee address [1] 304601 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 304601 0
Australia
Date submitted for ethics approval [1] 304601 0
22/11/2019
Approval date [1] 304601 0
Ethics approval number [1] 304601 0

Summary
Brief summary
Pelvic girdle pain is a common problem experienced during pregnancy that affects pregnant women significantly. Treatment options are needed for pelvic girdle pain in pregnancy especially when provided under ‘real-life’ circumstances and in terms that matter to the patient. This study aims to investigate the feasibility of conducting a randomised controlled trial on the effectiveness of massage in treating pregnant women with pelvic girdle pain. The expected outcome from this study is information on recruitment, randomisation, and the outcome measures for use in a large-scale study. The industry partner will be able to teach massage using evidence-based research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97538 0
Dr Sarah Fogarty
Address 97538 0
a touch of health
PO Box 8218
Ferntree Gully
Vic 3156
Country 97538 0
Australia
Phone 97538 0
+61 405078914
Fax 97538 0
Email 97538 0
PPGPstudy@gmail.com
Contact person for public queries
Name 97539 0
Dr Sarah Fogarty
Address 97539 0
a touch of health
PO Box 8218
Ferntree Gully
Vic 3156
Country 97539 0
Australia
Phone 97539 0
+61 405078914
Fax 97539 0
Email 97539 0
PPGPstudy@gmail.com
Contact person for scientific queries
Name 97540 0
Dr Sarah Fogarty
Address 97540 0
a touch of health
PO Box 8218
Ferntree Gully
Vic 3156
Country 97540 0
Australia
Phone 97540 0
+61 405078914
Fax 97540 0
Email 97540 0
PPGPstudy@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data on outcomes such as pain, pelvic girdle questionnaire and quality of life.
When will data be available (start and end dates)?
Beginning 3 months following main results publication and ending 5 years from trial start date.
Available to whom?
The re-use of the data will only be allowed on a case-bycase basis at the discretion of the Primary Sponsor after an ethics committee has agreed that the new use of the data meets the requirements of ethics review.
Available for what types of analyses?
Data will be available for use by Dr Sarah Fogarty or other researchers for systematic review research or pelvic girdle pain research
How or where can data be obtained?
Access subject to approvals by Principal Investigator Dr Sarah Fogarty. Email PPGPstudy@gmail.com
What supporting documents are/will be available?
No other documents available
Summary results
No Results