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Completed

NCT Number: NCT05029492

Effect of Visceral Manipulation on PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Menstruation Disturbances Neoplasms Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

20 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-calorie diet

Other

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

Other names: Control group, Group (A)

Visceral manipulation with diet

Other

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)

Primary outcomes

  1. Change of menstrual complaints' severity

    Time frame: At baseline and after three months of the intervention.

    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.

Secondary outcomes

  1. Change in the levels of reproductive hormones (FSH, LH, LH/FSH ratio)

    Time frame: At baseline in the second day of menstruation and after three months of the intervention.

    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.

  2. Change in weight

    Time frame: At baseline and after three months of the intervention.

    A weight- height scale is used to assess body weight in kilograms.

  3. Change in Body mass index (BMI)

    Time frame: At baseline and after three months of the intervention.

    BMI is measured by the equation weight (Kg)/ height (m^2)

Sponsors and collaborators

Lead sponsor

Mahitab Mohammed Yosri Ibrahim

Other

Registry information

Official study title

Effect of Visceral Manipulation on Polycystic Ovarian Syndrome

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 31, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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