Effect of Visceral Manipulation on PCOS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Motivational Interviewing as an Intervention for PCOS

NCT02924025

Polycystic Ovary Syndrome Overweight and Obesity Motivation

COMPLETED NA

Short Term Ketogenic Diet in Polycictic Ovary Syndrome

NCT06469255

Polycystic Ovary Syndrome

COMPLETED NA

The Secretion of Incretin Hormones in Patients With Polycystic Ovary Syndrome

NCT02126592

Polycystic Ovary Syndrome

UNKNOWN

Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome

NCT01150539

Polycystic Ovary Syndrome Obesity

COMPLETED NA

The Impact of Time-restricted Eating on the Outcomes Associated With Polycystic Ovary Syndrome

NCT06204965

Polycystic Ovary Syndrome

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

an independent researcher assigned the participants to one of the two study groups, by opening sealed envelopes containing serially ordered numbers. An independent assessor analyzed the patients' blood samples for hormonal profile and another assessor blinded to patients' allocation interviewed the patients for the questionnaire and assessed the weight.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diet group

Giving a low caloric diet

Group Type ACTIVE_COMPARATOR

Low-calorie diet

Intervention Type OTHER

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

Visceral manipulation with diet group

Giving visceral manipulation added to a low-calorie diet

Group Type EXPERIMENTAL

Visceral manipulation with diet

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low-calorie diet

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

Intervention Type 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).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control group Group (A) Study group Group (B)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No