Single Centre Blinded Randomized Controlled Trial Evaluating the Effectiveness of Two Pelvic Support Garments

Study Overview
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Brief Summary
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This blinded randomized comparative trial aims to determine the effectiveness of a customized Dynamic Elastomeric Fabric Orthoses (DEFO) compared to a standard pelvic belt in: a) reducing pregnancy-related pelvic girdle pain (PGP), b) optimizing activity levels in pregnant women with PGP, c) improving quality of life for pregnant women with PGP d) cost effectiveness.

Detailed Description
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Pelvic girdle pain (PGP) occurs in an estimated 70% of pregnant women, of whom 25% have severe pain and 8% significant disability. Current methods of management, such as the use of rigid pelvic belts, are limited in their effectiveness. The Dynamic Elastomeric Fabric Orthoses (DEFO) has recently proven beneficial in managing PGP in athletes. There is a need to explore the potential use of DEFO for managing PGP during pregnancy. The primary aim of the study is to compare the effectiveness of a DEFO to a rigid 'off the shelf' pelvic support belt in terms of its effectiveness in reducing PGP during pregnancy. The secondary aims of the study are to compare the effectiveness of the DEFO to the rigid 'off the shelf' pelvic support belt in (a) optimizing activity levels in pregnant women with PGP, (b)improving quality of life for pregnant women with PGP. The relative cost effectiveness of these two interventions will also be compared.

Official Title
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Management of Antenatal Pelvic Girdle Pain Study (MAPS): a Single Centre Blinded Randomized Trial Evaluating the Effectiveness of Two Pelvic Support Garments

Conditions
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Pelvic Pain, Symphysis Pubis Dysfunction

Intervention / Treatment
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* Device: Customised Dynamic Elastomeric fabric Orthoses
* Device: Serola Sacroiliac Belt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women 20-36 weeks pregnant, who: report intermittent PGP (commenced or aggravated during pregnancy) which causes walking and/or stair climbing to be bothersome and are positive on at least 3 out of 7 pain provocation tests Exclusion Criteria: recent history/signs or symptoms indicative of serious causes of pain that might be inflammatory, infective, traumatic, neoplastic, degenerative or metabolic, i.e. trauma, unexplained weight loss, history of cancer, steroid use, drug abuse, HIV infection, immunosuppressed state, neurological symptoms/signs such as: bowel, bladder, sensory, motor, reflex involvement (cauda equina, lumbar disk lesion, spinal stenosis,) fever systemically unwell obstetric complications pain that does not improve with rest/severe disabling pain history of chronic back or pelvic pain requiring surgery focal inflammatory signs/tenderness of spine (spondylolisthesis) known skin allergy to lycra >36 weeks pregnant (production of customized DEFO will take approximately 1 week)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Customised Orthoses<br>Customised Dynamic Elastomeric Fabric Orthoses (DEFO) | Device: Customised Dynamic Elastomeric fabric Orthoses<br>* Eligible participants will be measured and fitted with a customised Dynamic Elastomeric Fabric Orthoses. The participant may require a re-fitting of the garment as they progress through their pregnancy. Participants will also be issued with standardised advice on PGP management via an information leaflet from Association of Chartered Physiotherapists in Women's health website.<br>* Other names: Pelvic Support Garment;|
| Active Comparator: Rigid 'off the shelf' pelvic support<br>Serola Sacroiliac Belt. | Device: Serola Sacroiliac Belt<br>* Eligible participants will be measured and fitted with a Serola sacroiliac belt. Participants will also be issued with standardised advice on PGP management via an information leaflet from Association of Chartered Physiotherapists in Women's health website.<br>* Other names: Pelvic Support garment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Levels | Change in pain levels at 2 weekly intervals will be measured by a self report numerical rating scale. | Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Activity Levels | Change in activity levels at 2 weekly intervals will be measured by a self report questionnaire. | Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum) | 
| Change in Quality of Life | Change in Quality of life at two weekly intervals will be measured by two self report questionnaires: (i) Short Form 36 - Item Health Survey (Version 2) (ii) Euroqol (EQ-5D) Health Questionnaire | Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthotic Devices, Pelvic Girdle pain, Symphysis Pubis Dysfunction, Sacroiliac Joint, Sacroiliitis, Physiotherapy, Physical Therapy