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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customised Orthoses | Experimental | Customised Dynamic Elastomeric Fabric Orthoses (DEFO) |
|
| Rigid 'off the shelf' pelvic support | Active Comparator | Serola Sacroiliac Belt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customised Dynamic Elastomeric fabric Orthoses | Device | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
women 20-36 weeks pregnant, who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Cameron | University of Plymouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom | ||
| University of Plymouth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16305268 | Background | Depledge J, McNair PJ, Keal-Smith C, Williams M. Management of symphysis pubis dysfunction during pregnancy using exercise and pelvic support belts. Phys Ther. 2005 Dec;85(12):1290-300. | |
| 20102541 | Background | Ekdahl L, Petersson K. Acupuncture treatment of pregnant women with low back and pelvic pain--an intervention study. Scand J Caring Sci. 2010 Mar;24(1):175-82. doi: 10.1111/j.1471-6712.2009.00704.x. Epub 2010 Jan 20. |
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|
|
| Serola Sacroiliac Belt | Device | 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. |
|
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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) |
| Plymouth |
| Devon |
| PL6 8BH |
| United Kingdom |
| 20117040 | Background | Robinson HS, Mengshoel AM, Bjelland EK, Vollestad NK. Pelvic girdle pain, clinical tests and disability in late pregnancy. Man Ther. 2010 Jun;15(3):280-5. doi: 10.1016/j.math.2010.01.006. Epub 2010 Feb 8. |
| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| D059388 | Pelvic Girdle Pain |
| D058566 | Sacroiliitis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059352 | Musculoskeletal Pain |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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