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

NCT01820013 | Completed DMC

• 1 other identifier: PGP-LC12
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Pelvic Pain; Symphysis Pubis Dysfunction

Keywords

Pelvic Girdle pain; Symphysis Pubis Dysfunction; Sacroiliac Joint; Sacroiliitis; Physiotherapy; Physical Therapy; Orthotic Devices

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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 Quality of Life

  Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)

Study Arms (2)

Customised Orthoses

EXPERIMENTAL

Customised Dynamic Elastomeric Fabric Orthoses (DEFO)

Device: Customised Dynamic Elastomeric fabric Orthoses

Rigid 'off the shelf' pelvic support

ACTIVE COMPARATOR

Serola Sacroiliac Belt.

Device: Serola Sacroiliac Belt

Interventions

Customised Dynamic Elastomeric fabric Orthoses DEVICE

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.

Also known as: Customised Dynamic Elastomeric Fabric Orthoses (DEFO), Pelvic Support Garment

Customised Orthoses

Serola Sacroiliac Belt DEVICE

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.

Also known as: Rigid 'off the shelf' Pelvic Support Belt, Pelvic Support garment

Rigid 'off the shelf' pelvic support

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (2)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

University of Plymouth

Plymouth, Devon, PL6 8BH, United Kingdom

Location

Related 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.

  PMID: 16305268 BACKGROUND

• 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.

  PMID: 20102541 BACKGROUND

• 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.

  PMID: 20117040 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain; Pelvic Girdle Pain; Sacroiliitis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Pain; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Lee Cameron

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Reader) in Physiotherapy

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: March 28, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

GB (2)