https://orcid.org/0000-0003-0000-0476
Abstract
Objective
To evaluate the efficacy of a memory-foam mattress and pillow plus standard treatment for nightly pelvic girdle pain (PGP) during pregnancy.
Method
In this randomised controlled study conducted at a tertiary-care hospital, 66 pregnant women who had nightly PGP were enrolled to receive standard treatment with the mattress and pillow (intervention group, n = 34) or solely standard treatment (control group, n = 32). The primary outcome was change in nightly posterior PGP on a visual analogue scale, VAS from baseline to 4 weeks. Secondary outcomes include nightly anterior PGP, the evening PGP score, estimated sleep duration, number of nightly wake-ups, daytime sleepiness (Epworth sleepiness scale), function (Pelvic Girdle Questionnaire), health-related quality of life, and pain catastrophizing.
Results
Forty-four women (67%) completed the treatment. The difference in nightly posterior pain intensity was significantly different in favour of the intervention group (VAS, 16.5 mm (95% CI 1.4:31.6) p = 0.028). Sleep duration increased within both groups (intervention group: 26 min, p = 0.022; control group: 14 min, p = 0.014) and the difference between groups was significant (p = 0.046). In addition, the intervention group indicated a decreased evening PGP intensity (p = 0.008) and fewer nightly wake-ups (p = 0.049). The control group showed a deterioration in function (Pelvic Girdle Questionnaire) (p = 0.018) and an increase in daytime sleepiness (Epworth sleepiness scale) (p = 0.021) from baseline to 4 weeks.
Conclusion
In conclusion, significantly lower nightly posterior PGP intensity was noted after the use of a mattress and pillow as an adjunct to standard treatment. Nightly PGP can have adverse effects on various aspects of the health and quality of life of pregnant women, and although the results of this study should be interpreted with caution considering the high drop-out rate and the inadequate statistical power, the findings indicate the potential for the use of such interventions to improve PGP in pregnant women.
Abbreviations
BMI, body mass index; CPAP, continuous positive airway pressure; ESS, Epworth sleepiness scale; EQ-VAS, European quality of life measure visual analogue scale; PCS, pain catastrophizing scale; PGP, pelvic girdle pain; PGQ, pelvic girdle questionnaire; PPPP-test, posterior pelvic pain provocation test; PROMS, patient reported outcomes; RCT, randomised controlled trial; VAS, visual analogue scale; SD, standard deviation.
Data Sharing Statement
Data can be made available on reasonable request to the corresponding author.
Ethics Approval and Informed Consent
Approval for this study was obtained from the Regional Medical Ethics Committee in Gothenburg, Sweden (0915152009/099-09). The study follows CONSORT guidelines and is registered at IRSCTN (No. ISRCTN13438272). All participants were informed as to the purpose of the study, in accordance with the Declaration of Helsinki and gave their written consent.
Acknowledgments
We thank the medical doctors and midwives at the antenatal units for their invaluable help with the recruitment of the participants. We also express our appreciation to all the women for their contributions to this study. We acknowledge statistician Nils-Gunnar Pehrsson at Statistiska Konsultgruppen for assistance with the study design, power calculation and randomisation. image is owned by and with courtesy from Dr Ejnell.
Author Contributions
All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval for the version to be published; and agreed to be accountable for all aspects of the work.
Disclosure
Dr Feldthusen, Dr Fagevik-Olsen and Dr Elden declare that they have no competing interest. Dr Ejnell is the owner of the mattress and pillow for treatment of sleep apnoea. The authors report no other conflicts of interest in this work.