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 nightly PGP (updated 18/03/2020, previously: 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
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 measure
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
15/06/2020
Reason abandoned (if study stopped)
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
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
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list