Effect of Visceral Manipulation on PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effect of Visceral Manipulation on Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05029492
• Other study ID #: P.T.REC/012/001044
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Low-calorie diet
Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahitab Mohammed Yosri Ibrahim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Change in weight	A weight- height scale is used to assess body weight in kilograms.	At baseline and after three months of the intervention.
Secondary	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.