Effect of Visceral Manipulation on PCOS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Visceral Manipulation on Polycystic Ovarian Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Low-calorie diet
* Other: Visceral manipulation with diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet group<br>Giving a low caloric diet | Other: Low-calorie diet<br>* Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.<br>* Other names: Group (A);|
| Experimental: Visceral manipulation with diet group<br>Giving visceral manipulation added to a low-calorie diet | Other: Visceral manipulation with diet<br>* Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A).<br>* Other names: Group (B);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of menstrual complaints' severity | The total score of menstruation- specific domain of polycystic ovarian syndrome questionnaire (PCOSQ) questions, calculated using the following equation: Number of patient/ group x number of questions/ domain. That total score was then used to determine the percentage of change from severity towards the optimal function. | At baseline and after three months of the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio) | Human LH and FSH enzyme linked immunosorbent assay (ELISA) kits were used to assess the level of LH and FSH in the blood sample taken from each patient. | At baseline in the second day of menstruation and after three months of the intervention. | 
| Change in weight | A weight- height scale is used to assess body weight in kilograms. | At baseline and after three months of the intervention. | 
| Change in Body mass index (BMI) | BMI is measured by the equation weight (Kg)/ height (m^2) | At baseline and after three months of the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Menstruation Disturbances, Caloric Restriction, Manipulation Therapy