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

NCT ID: NCT01820013

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-11-30

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.

Conditions

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Pelvic Pain Symphysis Pubis Dysfunction

Keywords

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Pelvic Girdle pain Symphysis Pubis Dysfunction Sacroiliac Joint Sacroiliitis Physiotherapy Physical Therapy Orthotic Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Customised Orthoses

Customised Dynamic Elastomeric Fabric Orthoses (DEFO)

Group Type EXPERIMENTAL

Customised Dynamic Elastomeric fabric Orthoses

Intervention Type 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.

Rigid 'off the shelf' pelvic support

Serola Sacroiliac Belt.

Group Type ACTIVE_COMPARATOR

Serola Sacroiliac Belt

Intervention Type 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.

Interventions

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Customised Dynamic Elastomeric fabric Orthoses

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.

Intervention Type DEVICE

Serola Sacroiliac Belt

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.

Intervention Type DEVICE

Other Intervention Names

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Customised Dynamic Elastomeric Fabric Orthoses (DEFO) Pelvic Support Garment Rigid 'off the shelf' Pelvic Support Belt Pelvic Support garment

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Plymouth

OTHER

Sponsor Role lead

Responsible Party

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Jenny Freeman

Associate Professor (Reader) in Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lee Cameron

Role: PRINCIPAL_INVESTIGATOR

University of Plymouth

Locations

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Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Site Status

University of Plymouth

Plymouth, Devon, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 16305268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20102541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20117040 (View on PubMed)

Other Identifiers

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PGP-LC12

Identifier Type: -

Identifier Source: org_study_id