Contact information
Type
Scientific
Primary contact
Prof Rob de Bie
ORCID ID
Contact details
Department of Epidemiology
PO Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882366
ra.debie@epid.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PPBS-study
Study information
Scientific title
Acronym
PPGP - Peri-partal Pelvic Girdle Pain (PPBS - Peri Partaal Bekkenpijn Syndroom)
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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
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'.
Overall trial start date
01/01/2001
Overall trial end date
30/06/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
127
Participant exclusion criteria
Women diagnosed with a relevant specific pathology are excluded.
Recruitment start date
01/01/2001
Recruitment end date
30/06/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Epidemiology
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
Dutch Health Care Insurance Board (College Voor Zorgverzekeringen) (The Netherlands)
Sponsor details
PO Box 320
Diemen
1110 AH
Netherlands
+31 (0)20 797 8555
info@cvz.nl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Dutch Health Care Insurance Board (College voor Zorgverzekeringen) (PPBS-study)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Long-tern results in http://www.ncbi.nlm.nih.gov/pubmed/18513390
Short-term results in http://www.ncbi.nlm.nih.gov/pubmed/16504165
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15619331
Publication citations
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Protocol
Bastiaenen CH, de Bie RA, Wolters PM, Vlaeyen JW, Bastiaanssen JM, Klabbers AB, Heuts A, van den Brandt PA, Essed GG, Treatment of pregnancy-related pelvic girdle and/or low back pain after delivery design of a randomized clinical trial within a comprehensive prognostic cohort study [ISRCTN08477490]., BMC Public Health, 2004, 4, 67, doi: 10.1186/1471-2458-4-67.
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Bastiaenen CH, de Bie RA, Vlaeyen JW, Goossens ME, Leffers P, Wolters PM, Bastiaanssen JM, Brandt PA, Essed GG, Long-term effectiveness and costs of a brief self-management intervention in women with pregnancy-related low back pain after delivery., BMC Pregnancy Childbirth, 2008, 8, 19, doi: 10.1186/1471-2393-8-19.
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Bastiaenen CH, de Bie RA, Wolters PM, Vlaeyen JW, Leffers P, Stelma F, Bastiaanssen JM, Essed GG, van den Brandt PA, Effectiveness of a tailor-made intervention for pregnancy-related pelvic girdle and/or low back pain after delivery: short-term results of a randomized clinical trial [ISRCTN08477490]., BMC Musculoskelet Disord, 2006, 7, 19, doi: 10.1186/1471-2474-7-19.