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

This study is currently recruiting participants.
Verified March 2013 by University of Plymouth
Sponsor:
Information provided by (Responsible Party):
Jenny Freeman, University of Plymouth
ClinicalTrials.gov Identifier:
NCT01820013
First received: March 15, 2013
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Pelvic Pain
Symphysis Pubis Dysfunction
Device: Customised Dynamic Elastomeric fabric Orthoses
Device: Serola Sacroiliac Belt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Management of Antenatal Pelvic Girdle Pain Study (MAPS): a Single Centre Blinded Randomized Trial Evaluating the Effectiveness of Two Pelvic Support Garments

Resource links provided by NLM:


Further study details as provided by University of Plymouth:

Primary Outcome Measures:
  • Change in Pain Levels [ Time Frame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum) ] [ Designated as safety issue: No ]
    Change in activity levels at 2 weekly intervals will be measured by a self report questionnaire.

  • Change in Quality of Life [ Time Frame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum) ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 72
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Customised Orthoses
Customised Dynamic Elastomeric Fabric Orthoses (DEFO)
Device: 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.
Other Names:
  • Customised Dynamic Elastomeric Fabric Orthoses (DEFO)
  • Pelvic Support Garment
Active Comparator: Rigid 'off the shelf' pelvic support
Serola Sacroiliac Belt.
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.
Other Names:
  • Rigid 'off the shelf' Pelvic Support Belt
  • Serola Sacroiliac Belt
  • Pelvic Support garment

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01820013

Contacts
Contact: Jenny Freeman 01752 588835 jenny.freeman@plymouth.ac.uk
Contact: Lee Cameron 01752 587541 lee.cameron@plymouth.ac.uk

Locations
United Kingdom
Royal Cornwall Hospital Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Contact: Karen Watkins       karen.watkins@RCHT.nhs.uk   
Principal Investigator: Lee Cameron         
University of Plymouth Recruiting
Plymouth, Devon, United Kingdom, PL6 8BH
Contact: Lee Cameron       lee.cameron@plymouth.ac.uk   
Contact: Jenny Freeman       jenny.freeman@plymouth.ac.uk   
Principal Investigator: Lee Cameron         
Sponsors and Collaborators
University of Plymouth
Investigators
Principal Investigator: Lee Cameron University of Plymouth
  More Information

Additional Information:
Publications:
Responsible Party: Jenny Freeman, Associate Professor (Reader) in Physiotherapy, University of Plymouth
ClinicalTrials.gov Identifier: NCT01820013     History of Changes
Other Study ID Numbers: PGP-LC12
Study First Received: March 15, 2013
Last Updated: March 22, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Plymouth:
Pelvic Girdle pain
Symphysis Pubis Dysfunction
Sacroiliac Joint
Sacroiliitis
Physiotherapy
Physical Therapy
Orthotic Devices

Additional relevant MeSH terms:
Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014