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

Pelvic Pain Clinical Trial

— MAPS  

Official title:

Management of Antenatal Pelvic Girdle Pain Study (MAPS): a Single Centre Blinded Randomized Trial Evaluating the Effectiveness of Two Pelvic Support Garments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820013
• Other study ID #: PGP-LC12
• Status: Completed
• Phase: N/A
• First received: March 15, 2013
• Last updated: December 23, 2015
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Girdle Pain
• Pelvic Pain
• Symphysis Pubis Dysfunction

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Plymouth	Plymouth	Devon
United Kingdom	Royal Cornwall Hospital	Truro	Cornwall

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View Citation

Robinson HS, Mengshoel AM, Bjelland EK, Vøllestad 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Levels	Change in pain levels at 2 weekly intervals will be measured by a self report numerical rating scale.	Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)	No
Secondary	Change in Activity Levels	Change in activity levels at 2 weekly intervals will be measured by a self report questionnaire.	Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)	No
Secondary	Change in Quality of Life	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	Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)	No

External Links

•   Link to a pregnancy-related pelvic girdle pain for mothers-to-be and new mothers information leaflet