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

Primary Purpose

Pelvic Pain, Symphysis Pubis Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Customised Dynamic Elastomeric fabric Orthoses

Serola Sacroiliac Belt

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring Pelvic Girdle pain, Symphysis Pubis Dysfunction, Sacroiliac Joint, Sacroiliitis, Physiotherapy, Physical Therapy, Orthotic Devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Royal Cornwall Hospital
University of Plymouth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Customised Orthoses

Rigid 'off the shelf' pelvic support

Arm Description

Customised Dynamic Elastomeric Fabric Orthoses (DEFO)

Serola Sacroiliac Belt.

Outcomes

Primary Outcome Measures

Change in Pain Levels

Change in pain levels at 2 weekly intervals will be measured by a self report numerical rating scale.

Secondary Outcome Measures

Change in Activity Levels

Change in activity levels at 2 weekly intervals will be measured by a self report questionnaire.

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

Full Information

NCT ID

NCT01820013

First Posted

March 15, 2013

Last Updated

December 23, 2015

Sponsor

University of Plymouth

1. Study Identification

Unique Protocol Identification Number

NCT01820013

Brief Title

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

Acronym

MAPS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Plymouth

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain, Symphysis Pubis Dysfunction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Customised Orthoses

Arm Type

Experimental

Arm Description

Customised Dynamic Elastomeric Fabric Orthoses (DEFO)

Arm Title

Rigid 'off the shelf' pelvic support

Arm Type

Active Comparator

Arm Description

Serola Sacroiliac Belt.

Intervention Type

Device

Intervention Name(s)

Customised Dynamic Elastomeric fabric Orthoses

Other Intervention Name(s)

Customised Dynamic Elastomeric Fabric Orthoses (DEFO), Pelvic Support Garment

Intervention Description

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

Intervention Name(s)

Serola Sacroiliac Belt

Other Intervention Name(s)

Rigid 'off the shelf' Pelvic Support Belt, Pelvic Support garment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Pain Levels

Description

Change in pain levels at 2 weekly intervals will be measured by a self report numerical rating scale.

Time Frame

Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)

Secondary Outcome Measure Information:

Title

Change in Activity Levels

Description

Change in activity levels at 2 weekly intervals will be measured by a self report questionnaire.

Time Frame

Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)

Title

Change in Quality of Life

Description

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

Time Frame

Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lee Cameron

Organizational Affiliation

University of Plymouth

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Cornwall Hospital

City

Truro

State/Province

Cornwall

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

Facility Name

University of Plymouth

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8BH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

16305268

Citation

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.

Results Reference

background

PubMed Identifier

20102541

Citation

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.

Results Reference

background

PubMed Identifier

20117040

Citation

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.

Results Reference

background

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

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