Condition category
Pregnancy and Childbirth
Date applied
20/04/2018
Date assigned
27/04/2018
Last edited
27/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Three out of ten pregnant women experience pelvic girdle pain (PGP) and one of ten experiences severe pain. Many of these women have difficulties finding a pain-free sleeping position. This can result in frequent awakenings during the night and daytime tiredness.
A newly developed mattress and pillow have been specially designed for patients with sleep apnea (breathing problems when asleep) so that they avoid sleeping on their back and can achieve a comfortable sleeping position on their side. The newly developed mattress and pillow consists of stretchy foam that shapes around the body. The pillow is separated from the mattress, resulting in a unique possibility to support the shoulder and pelvis when sleeping on the side.
The aim of this study is to investigate whether this mattress and pillow, when added to standard treatment, can decrease pain and sick leave, improve daily function, sleep quality, subjective sleeping time and quality of life, and influence thoughts about pain in pregnant women with PGP.

Who can participate?
Pregnant women with moderate or severe PGP in the evening.

What does the study involve?
An independent specially-trained physiotherapist will assess patients who are eligible and willing to participate in the study. This assessment will include a physical examination and filling out questionnaires. All randomized participants will receive standard treatment at the first visit. Standard treatment consists of general information about the condition and anatomy of the back and pelvis. Advice is given on the participant's activities of daily living as well as exercises to do at home that are designed to increase strength in the abdominal (lower body) and gluteal (buttock) muscles. Both groups will be offered the mattress and pillow. Group 1 (the control group) can use the mattress and pillow after 4 weeks of standard treatment alone and group 2 (the intervention group) can use them in addition to standard treatment from the start of the study. Women who are satisfied with the mattress and pillow can borrow them through their pregnancy. The same physical examination and self-assessed questionnaires of pain, function, sleep quality, subjective sleeping time, sickness leave, quality of life and thoughts about pain will be re-done after 4 and 8 weeks.
In a sub-study, sleep quality will be investigated in some of each group using polysomnography (sleep tracking).

What are the possible benefits and risks of participating?
Possible benefits of participating in the study are that all women get additional treatment as well as standard treatment and that women who are satisfied with the mattress and pillow can borrow them through their pregnancy. It has been confirmed in earlier studies as well as in clinical practice that there are no side effects reported of sleeping with this mattress and pillow. A possible risk is that the exercises that the women do at home can give short-lasting pain.

Where is the study run from?
Sahlgrenska University Hospital in Gothenburg, Sweden

When is the study starting and how long is it expected to run for?
The trial is recruiting between April 2018 and March 2019.

Who is funding the study?
The Healthcare Board, Region Västra Götaland

Who is the main contact?
Professor Helen Elden, helen.elden@gu.se


Trial website

Contact information

Type

Scientific

Primary contact

Prof Helen Elden

ORCID ID

Contact details

Sahlgrenska University hospital/ East hospital
Gothenburg
41650
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VGRFOU-242761

Study information

Scientific title

Effects of a newly developed mattress and pillow for pelvic girdle pain during pregnancy : a randomized controlled cross-over trial.

Acronym

N/A

Study hypothesis

Null hypothesis: there is no difference in pelvic girdle pain (intensity on a visual analogue scale) in pregnant women after 4 weeks of standard treatment alone and pelvic girdle pain (intensity on a visual analogue scale) in pregnant women after 4 weeks of sleeping on a newly developed mattress and pillow as adjunct to standard treatment.

Ethics approval

The Regional ethical review board in Gothenburg, 05/03/2018, 100-18

Study design

Randomized controlled cross-over multicenter trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Pelvic girdle pain (PGP) in pregnant women

Intervention

An independent specially-trained physiotherapist will assess patients who are eligible and willing to participate in the study. This assessment will include a detailed standardized physical examination and collection of baseline data through self-assessment questionnaires. All randomised participants will receive standard treatment at the inclusion visit. Standard treatment consists of general information about the condition and anatomy of the back and pelvis. Adequate advice and practice are also given with respect to the participant's activities of daily living as well as home programme exercises designed to increase strength in the abdominal and gluteal muscles. The newly developed mattress and pillow consists of viscoelastic foam, which shapes around the body. The pillow is separated from the mattress, resulting in a unique possibility to offload the shoulder and pelvis and receive a comfortable sleeping position in a lateral position. Both groups will be offered the mattress and pillow. Group 1 after 4 weeks of standard treatment alone and group 2 (intervention group) as adjunct to standard treatment after randomisation at the inclusion visit. Women who are satisfied with the mattress and pillow can borrow them through their pregnancy. The same assessment and self-assessed questionnaires of pain, function, sleep quality, subjective sleeping time, sickness leave, quality of life and thoughts about pain will be evaluated after 4 and 8 weeks.
In a sub study, sleep quality will be investigated in a sub-group of the participants (10 from each group) using polysomnography.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Participant's score of the intensity of their present pelvic pain on a 100-point visual analogue scale (VAS), every morning and every evening in a diary

Secondary outcome measures

1. The Swedish version of the Pelvic Girdle Questionnaire (PGQ), a questionnaire specific for pelvic girdle pain in pregnancy
2. EuroQoL questionnaire measuring health function and health-related quality of life
3. Pain catastrophizing scale (PCS) a questionnaire measuring thoughts about pain
4. Epworth sleepiness scale (ESS) and subjective sleeping time (number of hours)
All questionnaires will be filled at baseline, 4 and 8 weeks.

Sleep registration (polysomnography) will be performed during 2-3 nights in 20 participants (10 in each group)

Overall trial start date

23/03/2018

Overall trial end date

23/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Otherwise healthy
2. Pregnant with singleton fetus and have completed 12-30 gestational weeks
3. Well integrated in the Swedish language
4. Pregnancy-related PGP according to the European Guidelines of diagnosis and treatment of PGP
5. Mean self-reported evening pain intensity of ≥40 mm (on a VAS) in their baseline diary, i.e. 5-7 days before the screening visit

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70

Participant exclusion criteria

Other pain conditions

Recruitment start date

15/04/2018

Recruitment end date

31/03/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Sahlgrenska University hospital
Gothenburg
S-413 45
Sweden

Trial participating centre

Womens health clinic in Partille
Partille
S-433 23
Sweden

Trial participating centre

Womens health clinic in Gråbo
Gothenburg
S-443 42
Sweden

Sponsor information

Organisation

The Healthcare Board, Region Västra Götaland (Hälso- och sjukvårdsstyrelsen)

Sponsor details

Regionens Hus
Göteborg
405 44
Sweden

Sponsor type

Research council

Website

Funders

Funder type

Not defined

Funder name

The Healthcare Board, Region Västra Götaland (Hälso- och sjukvårdsstyrelsen)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes