Condition category
Pregnancy and Childbirth
Date applied
25/04/2010
Date assigned
30/06/2010
Last edited
31/07/2017
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 Kåre Birger Hagen

ORCID ID

Contact details

Diakonhjemmet Hospital
POBOX 23
Vinderen
0319 Oslo
Oslo
0319
Norway
-
k.b.hagen@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Can tailored exercises in pregnancy prevent low back and pelvic girdle pain? A randomised controlled trial

Acronym

BeST

Study hypothesis

Supervised exercises adapted to pregnant women can reduce the proportion reporting low back- or pelvic girdle pain.

Ethics approval

Regional Committee for Medical and Health Research Ethics South East (REK), 21/12/2007, ref: 1.2007.2296

Study design

Randomised controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Maternity care

Intervention

The participants in the intervention group were referred to one of two special trained physical therapists and received tailored supervised exercise in groups once a week and advice to do daily home exercise.
Attention was paid to body awareness and ergonomic advice in specific in real-life situations. The main focus, however was on specific training of the transversely oriented abdominal muscles with coactivation of the lumbar multifidus at the lumbosacral region and stretching the hip abductors
The control group did not receive any special treatment (treatment as usual).
The total intervention was carried out between gestation weeks 20 to 36. A maximum of 16 weeks. There was no further follow-up beyond gestation week 36.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The proportion of women experiencing pain in the pelvic girdle or lumbar spine, measured at gestation weeks 24, 28, 32 and 36

Secondary outcome measures

1. Functional status, measured with the modified Roland Morris Disability Questionnaire (0-24 scale)
2. Low back- and lumbopelvic pain, measured using the VAS score (0-10 scale)
3. Health-related quality of life, measured with the SF-8 Health Survey
Outcomes were measured at gestation weeks 24, 28, 32 and 36

Overall trial start date

01/03/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

The Norwegian public health system offers all women free health care in maternity care units (MCU) during pregnancy. Healthy Norwegian speaking women aged 18-40 were included from two MCUs.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

260

Participant exclusion criteria

1. Pregnant women carrying twins
2. Inflammatory rheumatic disorders
3. Risk factors for miscarriage

Recruitment start date

01/03/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Norway

Trial participating centre

Diakonhjemmet Hospital
Oslo
0319
Norway

Sponsor information

Organisation

Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)

Sponsor details

Postboks 2704 St.Hanshaugen 0131 Oslo
Oslo
0131
Norway
-
post@fondet.fysio.no

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical or legal restrictions.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22282770

Publication citations

Additional files

Editorial Notes

31/07/2017: IPD sharing statement added. 25/07/2017: Publication reference added.