Peripartum pelvic pain during pregnancy and after delivery. A cohort and intervention study

ISRCTN ISRCTN08477490
DOI https://doi.org/10.1186/ISRCTN08477490
Secondary identifying numbers PPBS-study
Submission date
18/11/2004
Registration date
20/12/2004
Last edited
06/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rob de Bie
Scientific

Department of Epidemiology
PO Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 3882366
Email ra.debie@epid.unimaas.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymPPGP - Peri-partal Pelvic Girdle Pain (PPBS - Peri Partaal Bekkenpijn Syndroom)
Study objectivesPregnancy-related pelvic girdle and/or low back pain is a syndrome with an onset during pregnancy, characterized by pain in the lumbar-pelvic region and feelings of instability when standing and walking. After delivery most symptoms subside, but some women report persisting pain and a small group do not develop complaints until after delivery. Often symptoms have an impact on activities of daily life, participation in society and sometimes lead to a chronic disabling condition with considerable work absenteeism in the future.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPeripartum pelvic pain
InterventionExperimental intervention: Theoretical concepts of self-management and fear-avoidance were integrated in the treatment protocol. It is an individualized approach of 7-9 sessions with a frequency of once a week. Standardized information is presented through a treatment protocol for the therapists and booklets for the patients. Generally, a time contingent policy is followed in which women set the pace.

Usual care: A pain contingent regimen of relative (bed) rest and avoiding and limiting several day-to-day activities. Goal setting focused on disease management with an accent on biomedical factors.
Intervention typeOther
Primary outcome measurePrimary 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 measuresPain 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.

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).

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'.

The Short-Form 36 (SF-36) evaluated health status. We used the subscale 'general health'.
Overall study start date01/01/2001
Completion date30/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants127
Key inclusion criteriaThe 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.
Key exclusion criteriaWomen diagnosed with a relevant specific pathology are excluded.
Date of first enrolment01/01/2001
Date of final enrolment30/06/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Department of Epidemiology
Maastricht
6200 MD
Netherlands

Sponsor information

Dutch Health Care Insurance Board (College Voor Zorgverzekeringen) (The Netherlands)
Government

PO Box 320
Diemen
1110 AH
Netherlands

Phone +31 (0)20 797 8555
Email info@cvz.nl

Funders

Funder type

Government

Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (PPBS-study)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article Protocol 24/12/2004 Yes No
Results article Short-term results 27/02/2006 Yes No
Results article Long-tern results 30/05/2008 Yes No