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

ISRCTN	ISRCTN08477490
DOI	https://doi.org/10.1186/ISRCTN08477490
Protocol serial number	PPBS-study
Sponsor	Dutch Health Care Insurance Board (College Voor Zorgverzekeringen) (The Netherlands)
Funder	Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PPGP - Peri-partal Pelvic Girdle Pain (PPBS - Peri Partaal Bekkenpijn Syndroom)
Study objectives	Pregnancy-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) studied	Peripartum pelvic pain
Intervention	Experimental 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 type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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. 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'.
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	127
Key inclusion criteria	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.
Key exclusion criteria	Women diagnosed with a relevant specific pathology are excluded.
Date of first enrolment	01/01/2001
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Epidemiology

Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

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