Management of Chronic Post-Partum Pelvic Girdle Pain Study

NCT02648607 | Completed

• 1 other identifier: PGP-LC15
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

Pelvic Girdle Pain (PGP) during pregnancy occurs in approximately 70% of females and 38% of women continue to suffer PGP symptoms beyond 12 weeks following delivery. PGP post- partum causes pain during everyday activities that impacts negatively on health related quality of life and is associated with significant healthcare and societal costs. These women are often referred to physiotherapy, however management is difficult and there is a weak evidence base for its management. Alongside the provision of advice and information, physiotherapists commonly prescribe orthoses such as a rigid belt with the aim of optimising pelvic stability and reducing pain. More recently a novel customised Dynamic Elastomeric Fabric Orthosis has been developed as an alternative to an 'off the shelf' pelvic belt. No studies have investigated their effectiveness in complementing standard physiotherapy advice and management. The investigators will undertake a comprehensive systematic review of the literature to critically evaluate the evidence base for the conservative management of chronic post-partum PGP. This will inform a single case experimental design. Here eight AB single case studies will be performed with the point of intervention being randomised between subjects. The use of a randomisation test permits subsequent statistical analyses of group effects. Participants' pain, activity levels, and quality of life will be evaluated along with subjective changes in confidence and urinary incontinence. Adherence to orthosis use will be diarised. Exit interviews will assess aspects such as the appropriateness of the outcome measures and acceptability of the intervention that will help to inform future clinical trials.

Conditions

Pelvic Girdle Pain; Symphysis Pubis Dysfunction

Keywords

Pelvic Girdle Pain; Chronic Pelvic Girdle Pain; Symphysis Pubis Dysfunction; Sacroiliac Joint Dysfunction; Physiotherapy; Physical Therapy; Orthoses; Orthosis; Orthotic Devices

Outcome Measures

Primary Outcomes (1)

• Pain Levels

  Change in pain levels at 1 weekly intervals will be measured by a self-report numerical pain rating scale

  Baseline (Pre intervention), 1 weekly intervals for 8, 9, 10 weeks (dependent on baseline randomisation), then a following 8,9,10 weeks Intervention (total 16 weeks)

Secondary Outcomes (2)

• Activity Levels

  Baseline (Pre intervention), 1 weekly intervals for 8, 9, 10 weeks (dependent on baseline randomisation), then a following 8,9,10 weeks Intervention (total 16 weeks)

• Quality if Life

  Baseline (Pre intervention), 1 weekly intervals for 8, 9, 10 weeks (dependent on baseline randomisation), then a following 8,9,10 weeks Intervention (total 16 weeks)

Study Arms (1)

Customised Orthosis

EXPERIMENTAL

Customised Dynamic Elastomeric Fabric Orthosis (DEFO)

Device: Customised Dynamic Elastomeric Fabric Orthosis (DEFO)

Interventions

Customised Dynamic Elastomeric Fabric Orthosis (DEFO) DEVICE

Eligible participants will be measured and fitted with a customised Dynamic Elastomeric Fabric Orthosis (DEFO). 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: Pelvic Support Garment, Customised Dynamic Elastomeric Fabric Orthosis

Customised Orthosis

Eligibility Criteria

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

You may qualify if:

• have symptoms that continued for \> 3 months following birth,
• have PGP that causes walking and/or stair climbing to be bothersome (as determined by a score of at least 2 on a 10 point visual analogue scale)
• are positive on at least 3 out of 7 pain provocation tests (see screening section below)

You may not qualify if:

• A recent history/signs or symptoms indicative of serious causes of pain that might be inflammatory infective, traumatic, neoplastic, degenerative or metabolic.
• trauma
• Indicators of serious pathology
• steroid use
• drug abuse
• HIV infection
• immunosuppressed state
• neurological symptoms/signs (including cauda-equina)
• fever
• systemically unwell
• obstetric complications
• pain that does not improve with rest/severe disabling pain
• history of chronic back or pelvic pain requiring surgery.
• a known skin allergy to Lycra

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (2)

Southmead Hospital

Bristol, Avon, BS10 5NB, United Kingdom

Location

University of Plymouth

Plymouth, Devon, PL6 8BH, United Kingdom

Location

Related Publications (9)

• Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieen JH, Wuisman PI, Ostgaard HC. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004 Nov;13(7):575-89. doi: 10.1007/s00586-003-0615-y. Epub 2004 Aug 27.

  PMID: 15338362 BACKGROUND

• Wang SM, Dezinno P, Maranets I, Berman MR, Caldwell-Andrews AA, Kain ZN. Low back pain during pregnancy: prevalence, risk factors, and outcomes. Obstet Gynecol. 2004 Jul;104(1):65-70. doi: 10.1097/01.AOG.0000129403.54061.0e.

  PMID: 15229002 BACKGROUND

• Noren L, Ostgaard S, Nielsen TF, Ostgaard HC. Reduction of sick leave for lumbar back and posterior pelvic pain in pregnancy. Spine (Phila Pa 1976). 1997 Sep 15;22(18):2157-60. doi: 10.1097/00007632-199709150-00013.

  PMID: 9322326 BACKGROUND

• Gutke A, Sjodahl J, Oberg B. Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial. J Rehabil Med. 2010 Nov;42(10):929-35. doi: 10.2340/16501977-0615.

  PMID: 21031289 BACKGROUND

• van de Pol G, de Leeuw JR, van Brummen HJ, Bruinse HW, Heintz AP, van der Vaart CH. The Pregnancy Mobility Index: a mobility scale during and after pregnancy. Acta Obstet Gynecol Scand. 2006;85(7):786-91. doi: 10.1080/00016340500456373.

  PMID: 16817074 BACKGROUND

• Robinson HS, Mengshoel AM, Veierod MB, Vollestad N. Pelvic girdle pain: potential risk factors in pregnancy in relation to disability and pain intensity three months postpartum. Man Ther. 2010 Dec;15(6):522-8. doi: 10.1016/j.math.2010.05.007.

  PMID: 20621546 BACKGROUND

• Fitzgerald CM, Santos LR, Mallinson T. The association between pelvic girdle pain and urinary incontinence among pregnant women in the second trimester. Int J Gynaecol Obstet. 2012 Jun;117(3):248-50. doi: 10.1016/j.ijgo.2012.01.014. Epub 2012 Mar 28.

  PMID: 22459920 BACKGROUND

• Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.

  PMID: 18259783 BACKGROUND

• Sawle L, Freeman J, Marsden J, Matthews MJ. Exploring the effect of pelvic belt configurations upon athletic lumbopelvic pain. Prosthet Orthot Int. 2013 Apr;37(2):124-31. doi: 10.1177/0309364612448806. Epub 2012 Jul 2.

  PMID: 22751218 BACKGROUND

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Lee Cameron

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Locations

GB (2)