Status:
COMPLETED
Single Centre Blinded Randomized Controlled Trial Evaluating the Effectiveness of Two Pelvic Support Garments
Lead Sponsor:
University of Plymouth
Conditions:
Pelvic Pain
Symphysis Pubis Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
NA
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-re...
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,...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01820013
Start Date
November 1 2012
End Date
November 1 2014
Last Update
December 24 2015
Active Locations (2)
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1
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LJ
2
University of Plymouth
Plymouth, Devon, United Kingdom, PL6 8BH