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

University of Plymouth

Status

Completed

Conditions

Symphysis Pubis Dysfunction

Pelvic Pain

Treatments

Device: Customised Dynamic Elastomeric fabric Orthoses

Device: Serola Sacroiliac Belt

Study type

Interventional

Funder types

Other

Identifiers

NCT01820013

PGP-LC12

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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)