Effect of Visceral Manipulation on PCOS

Effect of Visceral Manipulation on Polycystic Ovarian Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Low-calorie diet; Other: Visceral manipulation with diet

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 34 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Diet group; Giving a low caloric diet	Other: Low-calorie diet; Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.; Other Names: Control group; Group (A)
EXPERIMENTAL: Visceral manipulation with diet group; Giving visceral manipulation added to a low-calorie diet	Other: Visceral manipulation with diet; 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).; Other Names: Study group; Group (B)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Mahitab Mohammed Yosri Ibrahim
• Investigators: Principal Investigator: Mahitab Yosri, Lecturer of women's health, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: August 15, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (ACTUAL): August 31, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; Caloric Restriction; Menstruation Disturbances; Manipulation Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: P.T.REC/012/001044