Status:
UNKNOWN
Trial for the Treatment of Pelvic and Back Pain in Pregnancy
Lead Sponsor:
University College Cork
Conditions:
Pelvic Girdle Pain
Symphysio Pubic Dysfunction
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief Summary
The investigators aim to conduct a prospective open label randomized controlled trial to test the hypothesis that following initial assessment by a physiotherapist, group care exercise class is as eff...
Detailed Description
Back pain is reported to affect at least 75% of women at some stage during their pregnancy. In the United States one review found that approximately a third of women find back pain in pregnancy a seve...
Eligibility Criteria
Inclusion
- Pregnant women (primigravida and multigravida) from 20-35 weeks of gestation attending Cork University Maternity Hospital (CUMH) low risk antenatal clinics who are referred to the physiotherapy department by their health care provider or following self referral with back pain or pelvic pain will be assessed for inclusion in the trial.
- Women referred to the physiotherapy department with symptoms of PGP will be assessed on presentation by a one of six departmental physiotherapists specializing in women's health.
- To make the diagnosis of PGP the following tests will be performed as per the European Guidelines on the diagnosis and treatment of Pelvic Girdle Pain and a pain history taken as detailed.
- Sacroiliac joint assessment
- Posterior pelvic pain provocation test (P4)
- Gaenslen´s test.
- Compression of ASIS
- Distraction SIJ pain provocation test
- Assessment of Sulci depth in lumbar spine in neutral and extension
- Functional pelvic test 6.Active straight leg raise test (ASLR).
- Pain history (according to the criteria of Ostgaard)
- It is recommended that a pain history be taken with specific attention paid to pain patterns and irritability of PGP.
- There must be no nerve root syndrome. 9.The severity of pain must be related to motion.
- The diagnosis of PGP will be made if the patient has 2 or more of criteria 1-4 (Laslett's criteria) in combination with a negative McKenzie and negative neurological examination. Criteria 5-9 will be performed and assessed to try and improve diagnostic sensitivity and specificity as well as help exclude other pathologies that may cause pelvic and back pain.
Exclusion
- Women with other pain conditions, history of orthopaedic disease or surgery in the spine or pelvic girdle systemic disorders or if attending the high risk antenatal clinic in CUMH will be excluded from the study.
- If women volunteered a history of sexual abuse at any point of the study they would be excluded from the trial.
- Women who do not speak English fluently.
- Women with non viable pregnancies.
- Women who have already received treatment for PGP outside of this trial.
- Pregnant women who present who will not be booking at CUMH for their pregnancy or are not resident in the South West of Ireland
- Women with a history of severe PGP in previous pregnancies. Severe PGP will be defined as occurring less than 20 weeks gestation in a previous pregnancy or requiring crutches in a previous pregnancy or women with a history of PGP in 2 or more previous pregnancies.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00830934
Start Date
April 1 2009
End Date
September 1 2010
Last Update
January 28 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cork University Maternity Hospital
Cork, Cork, Ireland