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

Not Applicable

Completed

• Conditions: Symphysis Pubis Dysfunction; Pelvic Pain
• Interventions: Device: Serola Sacroiliac Belt; Device: Customised Dynamic Elastomeric fabric Orthoses

• Registration Number: NCT01820013
• Lead Sponsor: University of Plymouth

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-03-15
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-28
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rigid 'off the shelf' pelvic support	Serola Sacroiliac Belt	Serola Sacroiliac Belt.
Customised Orthoses	Customised Dynamic Elastomeric fabric Orthoses	Customised Dynamic Elastomeric Fabric Orthoses (DEFO)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Activity Levels	Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)	Change in activity levels at 2 weekly intervals will be measured by a self report questionnaire.
Change in Quality of Life	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 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

Trial Locations

Locations (2)

University of Plymouth; 🇬🇧 Plymouth, Devon, United Kingdom

Royal Cornwall Hospital; 🇬🇧 Truro, Cornwall, United Kingdom