Peripartum pelvic pain during pregnancy and after delivery. A cohort and intervention study
- Conditions
- Peripartum pelvic painPregnancy and ChildbirthPregnancy-related pelvic girdle and/or low back pain
- Registration Number
- ISRCTN08477490
- Lead Sponsor
- Dutch Health Care Insurance Board (College Voor Zorgverzekeringen) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 127
The trial is embedded in a cohort study (n = 7526) that is designed as a longitudinal, prospective study which studies the prevalence, etiology, severity and prognosis during pregnancy until 1 year after delivery. Participants are included in the cohort when they are at least 18 years old, pregnant (about 14 weeks) and well versed in the Dutch language. Women are included in the intervention study out of the cohort at the time of three weeks after delivery.
Inclusion criteria are: pain in the pelvic girdle and/or low back pain with an onset during pregnancy and a delay in recuperation. The frame of reference for the inclusion criteria is a random sample of 100 women out of the cohort without complaints, examined with the same protocol three weeks after delivery.
Women diagnosed with a relevant specific pathology are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary domain for improvement of the intervention was limitations in activities. Other important domains were the severity of the main complaint and global feeling of recovery.
- Secondary Outcome Measures
Name Time Method Pain was measured with two Visual Analog rating Scales (VAS) of the McGill Pain Questionnaire (MPQ-DLV) to record the intensity of pain the last week and day.<br><br>The impact on participation and autonomy (IPA) measured person-perceived restriction in participation and autonomy. The used subscales were self-care and appearance, mobility, leisure, social relationships and family role. Perceived participation is graded on a 5-point rating scale ranging from 0 (very good) to 4 (very poor).<br><br>Fear of movement was measured by the Dutch translation of the Tampa Scale for Kinesiophobia (TSK). We used the TSK and the both subscales 'fear avoidance' and 'harm'.<br><br>The Short-Form 36 (SF-36) evaluated health status. We used the subscale 'general health'.<br><br>