Can tailored exercises in pregnancy prevent low back and pelvic girdle pain?
| ISRCTN | ISRCTN95014448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95014448 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/04/2010
- Registration date
- 30/06/2010
- Last edited
- 31/07/2017
- 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 Kåre Birger Hagen
Scientific
Scientific
Diakonhjemmet Hospital
POBOX 23, Vinderen
0319 Oslo
Oslo
0319
Norway
| k.b.hagen@medisin.uio.no |
Study information
| Study design | Randomised controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Can tailored exercises in pregnancy prevent low back and pelvic girdle pain? A randomised controlled trial |
| Study acronym | BeST |
| Study objectives | Supervised exercises adapted to pregnant women can reduce the proportion reporting low back- or pelvic girdle pain. |
| Ethics approval(s) | Regional Committee for Medical and Health Research Ethics South East (REK), 21/12/2007, ref: 1.2007.2296 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | 260 |
| Key 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. |
| Key exclusion criteria | 1. Pregnant women carrying twins 2. Inflammatory rheumatic disorders 3. Risk factors for miscarriage |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Norway
Study participating centre
Diakonhjemmet Hospital
Oslo
0319
Norway
0319
Norway
Sponsor information
Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)
Government
Government
Postboks 2704 St.Hanshaugen 0131 Oslo
Oslo
0131
Norway
| post@fondet.fysio.no |
Funders
Funder type
Research organisation
Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No |
Editorial Notes
31/07/2017: IPD sharing statement added.
25/07/2017: Publication reference added.
