Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00830934
Eligibility Criteria:
Inclusion Criteria:
* 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
1. Posterior pelvic pain provocation test (P4)
2. Gaenslen´s test.
3. Compression of ASIS
4. Distraction SIJ pain provocation test
5. 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)
7.It is recommended that a pain history be taken with specific attention paid to pain patterns and irritability of PGP.
8.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 Criteria:
1. 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.
2. If women volunteered a history of sexual abuse at any point of the study they would be excluded from the trial.
3. Women who do not speak English fluently.
4. Women with non viable pregnancies.
5. Women who have already received treatment for PGP outside of this trial.
6. Pregnant women who present who will not be booking at CUMH for their pregnancy or are not resident in the South West of Ireland
7. 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Study:
NCT00830934
Study Brief:
Protocol Section:
NCT00830934