Clinical trial NCT05029492: Effect of Visceral Manipulation on PCOS
Official title: Effect of Visceral Manipulation on Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Menstruation Disturbances
Caloric Restriction
Manipulation Therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Polycystic ovarian women were assigned to either group (A), receiving a low-calorie diet for three months, or group (B), receiving the same diet as group (A) together with visceral manipulation of the pelvic organs and their related structures for the same study period (three months).
Primary purpose: TREATMENT

Brief summary: The study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women were randomly and equally assigned into the group (A) (Control group), who received a low caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received visceral manipulation to the pelvic organs and the related structures in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight, BMI, female reproductive hormones, and menstruation-related problems.

Detailed description: The current study was conducted to determine the effect of visceral manipulation on menstrual irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy, Cairo University. Patients were randomly assigned into two groups equal in number. Group (A) (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months, while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic organs and the related structures (8 sessions, once per week in the first month then once every other week for two months) in addition to the same low-calorie diet as the group (A). Evaluations pre and post-study for body weight, body mass index, female reproductive hormones \[luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio\] and menstruation-related problems were done by weight- height scale, blood analysis, and menstruation-specific domain of polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ), respectively.

Eligibility criteria: Inclusion Criteria:

* Women having PCOS.
* 25 ≤ BMI ≤ 30 Kg/m2.
* Waist/hip ratio ≤ 0.80.
* Women experiencing irregular menstrual cycles.

Exclusion Criteria:

* Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
* Having malignancy.
* Presence of reproductive disorders unrelated to PCOS.
* Presence of adrenal gland abnormalities.

Primary outcomes:
measure: Change of menstrual complaints' severity
timeFrame: At baseline and after three months of the intervention.
Secondary outcomes:
measure: Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)
timeFrame: At baseline in the second day of menstruation and after three months of the intervention.
measure: Change in weight
timeFrame: At baseline and after three months of the intervention.
measure: Change in Body mass index (BMI)
timeFrame: At baseline and after three months of the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mahitab Yosri, Lecturer of women's health
role: PRINCIPAL_INVESTIGATOR
References: