Effect of Visceral Manipulation on PCOS

NCT05029492 | Completed DMC

• 1 other identifier: P.T.REC/012/001044
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Menstruation Disturbances; Caloric Restriction; Manipulation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

• Change in weight

  At baseline and after three months of the intervention.

• Change in Body mass index (BMI)

  At baseline and after three months of the intervention.

Study Arms (2)

Diet group

ACTIVE COMPARATOR

Giving a low caloric diet

Other: Low-calorie diet

Visceral manipulation with diet group

EXPERIMENTAL

Giving visceral manipulation added to a low-calorie diet

Other: Visceral manipulation with diet

Interventions

Low-calorie diet OTHER

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

Also known as: Control group, Group (A)

Diet group

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).

Also known as: Study group, Group (B)

Visceral manipulation with diet group

Eligibility Criteria

• Age: 20 Years - 34 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women having PCOS.
• ≤ BMI ≤ 30 Kg/m2.
• Waist/hip ratio ≤ 0.80.
• Women experiencing irregular menstrual cycles.

You may not qualify if:

• Having cardiovascular diseases, diabetes mellitus, and/ or hypertension
• Having malignancy.
• Presence of reproductive disorders unrelated to PCOS.
• Presence of adrenal gland abnormalities.

Sponsors & Collaborators

• Mahitab Mohammed Yosri Ibrahim: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Menstruation Disturbances

Interventions

Caloric Restriction; Control Groups; Population Groups; Diet

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Demography; Population Characteristics

Study Officials

• Mahitab Yosri, Lecturer of women's health

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of physical therapy for women's health

Model Details: 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).

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 31, 2021
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 5, 2021

Record last verified: 2021-08