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
Scientific
Department of Epidemiology
PO Box 616
Maastricht
6200 MD
Netherlands
| Phone | +31 (0)43 3882366 |
|---|---|
| ra.debie@epid.unimaas.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2001 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
6200 MD
Netherlands
Sponsor information
Dutch Health Care Insurance Board (College Voor Zorgverzekeringen) (The Netherlands)
Government
Government
PO Box 320
Diemen
1110 AH
Netherlands
| Phone | +31 (0)20 797 8555 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
