Managing back pain in pregnancy using a support garment: a randomised trial.

OBJECTIVE: Large population studies have shown that low back pain affects about 50% of pregnant women. The aim of this study was to determine whether the use of the BellyBra in pregnant women with back pain is associated with changes in assessments of pain severity, physical activity and satisfaction with life after 3 weeks of intervention compared with tubigrip, a more generic form of support.
DESIGN: Randomised controlled trial.
SETTING: A tertiary referral hospital in Australia. POPULATION: Women between 20 and 36 weeks of pregnancy with lumbar back or posterior pelvic pain.
METHODS: Participants were randomised to the BellyBra (the study device) or to tubigrip (the control) by means of computer-generated numbered, sealed, opaque envelopes. MAIN OUTCOME MEASURES: The primary outcomes were pain severity and physical activity, and the secondary outcome was satisfaction with life.
RESULTS: One hundred and fifteen women consented to participate in the trial. Mean visual analogue scale scores of pain severity decreased from 6.1 to 4.5 in the study device group (P= 0.001) and from 6.0 to 4.7 in the control group (P= 0.003). There was no significant difference between the groups in this outcome (P= 0.61). However, the study device group demonstrated a significantly greater reduction in Likert scale assessments of the impact of back pain on sleeping (P= 0.007), getting up from a sitting position (P= 0.02) and walking (P= 0.001) than the control group. There was also a significant reduction in the use of analgesic medication in the study group (P= 0.01).
CONCLUSION: The BellyBra and tubigrip were both associated with a reduction in the severity of pregnancy-related low back pain. The BellyBra was more effective than tubigrip, however, in alleviating the impact of pain on a number of physical activities that constitute daily life.

RCT Entities:   Population Interventions Outcomes