Pelvic PainMAPSNCT01820013
Single Centre Blinded Randomized Controlled Trial Evaluating the Effectiveness of Two Pelvic Support Garments
A study testing Customised Dynamic Elastomeric fabric Orthoses and Serola Sacroiliac Belt in people with Pelvic Pain and Symphysis Pubis Dysfunction, run by University of Plymouth at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Pain, Symphysis Pubis Dysfunction
- What is being tested?
- Customised Dynamic Elastomeric fabric Orthoses and Serola Sacroiliac Belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- focal inflammatory signs/tenderness of spine (spondylolisthesis)
- known skin allergy to lycra
- >36 weeks pregnant (production of customized DEFO will take approximately 1 week)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Plymouth
Plymouth, Devon, PL6 8BH
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
About this study
Official title: Management of Antenatal Pelvic Girdle Pain Study (MAPS): a Single Centre Blinded Randomized Trial Evaluating the Effectiveness of Two Pelvic Support Garments
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.
Read the 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.
- Conditions
- Pelvic Pain, Symphysis Pubis Dysfunction
- Being tested
- Customised Dynamic Elastomeric fabric Orthoses, Serola Sacroiliac Belt
- Keywords
- Pelvic Girdle pain, Symphysis Pubis Dysfunction, Sacroiliac Joint, Sacroiliitis, Physiotherapy, Physical Therapy, Orthotic Devices
- Medical subject headings
- Pelvic Pain, Pelvic Girdle Pain, Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customised Dynamic Elastomeric fabric OrthosesDevice
Also called Customised Dynamic Elastomeric Fabric Orthoses (DEFO), Pelvic Support Garment
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 BeltDevice
Also called Rigid 'off the shelf' Pelvic Support Belt, Pelvic Support garment
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.
| Study group | Role | What they receive |
|---|---|---|
| Customised Orthoses | Experimental | Customised Dynamic Elastomeric Fabric Orthoses (DEFO) Receives: Device: Customised Dynamic Elastomeric fabric Orthoses |
| Rigid 'off the shelf' pelvic support | Active comparator | Serola Sacroiliac Belt. Receives: Device: Serola Sacroiliac Belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Levels
Change in pain levels at 2 weekly intervals will be measured by a self report numerical rating scale.
Measured: 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
Change in activity levels at 2 weekly intervals will be measured by a self report questionnaire.
Measured: 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
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
Measured: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Freeman, University of Plymouth
- Investigators
- Lee Cameron, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820013
- Sponsor's protocol ID
- PGP-LC12
- Acronym
- MAPS
- Status last verified
- Dec 2015
- First submitted
- 15 Mar 2013
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16305268Ekdahl 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.
PubMed 20102541Robinson 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.
PubMed 20117040
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Antenatal Pelvic Girdle Pain Study (MAPS): a Single Centre Blinded Randomized Trial Evaluating the Effectiveness of Two Pelvic Support Garments
- ClinicalTrials.gov ID
- NCT01820013
- Acronym / sponsor ID
- MAPS / PGP-LC12
- Conditions
- Pelvic Pain, Symphysis Pubis Dysfunction
- Keywords
- Pelvic Girdle pain, Symphysis Pubis Dysfunction, Sacroiliac Joint, Sacroiliitis, Physiotherapy, Physical Therapy, Orthotic Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customised Orthoses | Experimental | Device: Customised Dynamic Elastomeric fabric OrthosesCustomised Dynamic Elastomeric Fabric Orthoses (DEFO) |
| Rigid 'off the shelf' pelvic support | Active comparator | Device: Serola Sacroiliac BeltSerola Sacroiliac Belt. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customised Dynamic Elastomeric fabric OrthosesAlso: Customised Dynamic Elastomeric Fabric Orthoses (DEFO), Pelvic Support GarmentEligible 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. | Device | Customised Orthoses |
| Serola Sacroiliac BeltAlso: Rigid 'off the shelf' Pelvic Support Belt, Pelvic Support garmentEligible 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. | Device | Rigid 'off the shelf' pelvic support |
Primary outcome
Change in Pain Levels
Time frame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)
Change in pain levels at 2 weekly intervals will be measured by a self report numerical rating scale.
2 secondary outcomes
Change in Activity Levels
Time frame: 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
Time frame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Background: PubMed 16305268Depledge 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.
- Background: PubMed 20102541Ekdahl 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.
- Background: PubMed 20117040Robinson 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.
Related trials for Pelvic Pain
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Not yet recruitingPhase 2
Efficacy of Botulinum Toxin Versus Placebo on Pain and Health Related Quality of Life of Patients With Piriformis Muscle Syndrome
Piriformis Muscle Syndrome
Recruiting
HOme PElvic Floor Improvement Trainer Trial
Pelvic Pain, Pelvic Floor Dysfunction
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruiting
Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Cameron principal investigator
University of Plymouth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customised Dynamic Elastomeric fabric Orthoses and Serola Sacroiliac Belt in people with Pelvic Pain and Symphysis Pubis Dysfunction, run by University of Plymouth at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Levels (time frame: Baseline (pre intervention), 2 weekly intervals for potential of 20 weeks(pre-partum), 2 weekly intervals for 6 weeks (post-partum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820013, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.