Effects of a new mattress and pillow for nightly pelvic girdle pain during pregnancy

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2018
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. CONDITION: Pelvic girdle pain (PGP) in pregnant women ; Pregnancy and Childbirth ; Pelvic girdle pain PRIMARY OUTCOME: 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: 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); 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
Epistemonikos ID: cf73806cd9804fc165e9f136818e2d13e95a378d
First added on: Aug 24, 2024