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:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT04401566
Eligibility Criteria:
The inclusion criteria:
* to have chronic pelvic pain for more than six months,
* to have 5 pelvic pain orthopedic tests (active straight leg raise (ASLR), flexion abduction external rotation (FABER), pelvic pain provocation (P4), long dorsal ligament palpation (LDL), The Gaenslen Test) and at least three of the tests are positive,
* to have good communication skills and accept to attend the study.
The exclusion criteria:
* pregnant women who have had a pregnancy in the last year or who are breastfeeding;
* other causes of pain (eg pain unrelated to pelvic region relations, dermatological conditions, herpes, vulvovaginal atrophy);
* menopause;
* urogynecological conditions (i.e. pelvic prolapse grade \>3 according to the Pelvic Organ Prolapse - Quantification method (POP-Q) or a urinary or vaginal infection active or present in the last 3 months);
* history of pelvic floor surgery (e.g. corrective surgery for organ descent, urinary incontinence, hysterectomy, mesh surgery,TVT,TOT);
* previous pelvic floor rehabilitation treatments; 7) expected changes in medication that may affect the perception of pain (eg pain relievers, antidepressants);
* any other medical conditions that may interfere with the study procedures (eg hormonal, psychological, cardiovascular, hematological, neurological, pulmonary or renal);
* refusal to abstain from other treatments until the end of their participation in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04401566
Study Brief:
Protocol Section:
NCT04401566