Condition category
Pregnancy and Childbirth
Date applied
18/11/2004
Date assigned
20/12/2004
Last edited
06/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes