Clinical trial NCT01820013: Single Centre Blinded Randomized Controlled Trial Evaluating the Effectiveness of Two Pelvic Support Garments
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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Symphysis Pubis Dysfunction
Keywords: Pelvic Girdle pain
Symphysis Pubis Dysfunction
Sacroiliac Joint
Sacroiliitis
Physiotherapy
Physical Therapy
Orthotic Devices
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Pain Levels
timeFrame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)
Secondary outcomes:
measure: Change in Activity Levels
timeFrame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)
measure: Change in Quality of Life
timeFrame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)
Other outcomes:
Locations:
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Plymouth
country: United Kingdom
facility: University of Plymouth
state: Devon
Study officials:
affiliation: University of Plymouth
name: Lee Cameron
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.