Effects of Connective Tissue Manipulation on Menopausal Symptoms

March 26, 2024 updated by: SERAP ÖZGÜL, Hacettepe University

Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. This process involves some bothersome physical and psychological climacteric symptoms. The most common symptoms are vasomotor symptoms, psychological symptoms and sleep disturbances.

The aim of this study is to investigate the effects of Connective Tissue Manipulation (CTM) on vasomotor symptoms, psychological symptoms, sleep quality and quality of life in the postmenopausal period in a randomized placebo-controlled study design.

For this purpose, 58 postmenopausal women who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms; CTM or placebo control. The participants in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks, whereas the participant in the placebo control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcomes are frequency of vasomotor symptoms and vasomotor symptom score and they will be evaluated by daily diaries. Secondary outcomes are general severity of menopausal symptoms, psychological status, severity and effect of insomnia and quality of life associated with menopause. These outcomes will be assessed by questionnaires; "Menopausal Symptoms Rating Scale", "Depression-Anxiety-Stress 21 Scale", "Insomnia Severity Index", and "Menopause-Specific Quality of Life Scale". All outcome measurements will be evaluated at baseline and after the intervention period. Then, the results will be compared within groups and between two study groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Menopause is defined as the permanent cessation of menstruation as a result of the loss of ovarian follicular function. It is part of the natural aging process and occurs by declining the estrogen secretion from the ovaries. This process involves some bothersome physical and psychological climacteric symptoms that negatively influence the women's well-being and quality of life. The most common symptoms are vasomotor symptoms (hot flashes, sweating, night sweats), psychological symptoms (anxiety, depression, stress) and insomnia. Although hormonal and non-hormonal pharmacological methods are widely used effective approaches to control these symptoms, they have some risks or adverse side effects. For this reason, women tend to alternative therapies and complementary medicine methods to improve climacteric symptoms and their quality of life.

Connective tissue manipulation (CTM) is a manual reflex therapy method which aims to restore the balance between the sympathetic and parasympathetic components of the autonomic nervous system. It is characterised by special type of manual stroke which is applied to the connective tissue. These stretching maneuvers are applied to areas called "reflex zones", and create local, segmental and general therapeutic effects in the body.

The aim of this study is to investigate the effects of CTM on vasomotor symptoms, psychological symptoms, sleep quality and quality of life in the postmenopausal period in a randomized placebo controlled study design.

For this purpose, 58 postmenopausal women ages between 45 to 65 who meet the inclusion criteria and volunteer to participate in the study will be randomly assigned to one of the two research arms, CTM or placebo control. The women in the experimental group will receive CTM for 5-20 minutes, 3 times a week for 4 weeks. On the other hand, the women in the placebo control group will receive superficial massage with the head of the therapeutic ultrasound device for 15 minutes at the same frequency for 4 weeks. In this study, primary outcomes are frequency of vasomotor symptoms and vasomotor symptom score and they will be evaluated by daily diaries. Secondary outcomes are general severity of menopausal symptoms, psychological status, severity and effect of insomnia and quality of life associated with menopause. These outcomes will be assessed by questionnaires; "Menopausal Symptoms Rating Scale", "Depression-Anxiety-Stress 21 Scale", "Insomnia Severity Index", and "Menopause-Specific Quality of Life Scale". State anxiety, mobility and flexibility of connective tissue, autonomic functions and treatment satisfaction will also be evaluated in the study.

The diaries will be filled out for one week (7 days each); at the baseline and just after the completion of the study. All other outcome measurements will be performed before and immediately after the study is completed. The results will be compared within groups and between two study groups.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between the 45 and 65 years,
  • Being experienced at least 3 moderate or severe hot flashes, sweating or night sweats per day for at least 3 months,
  • Being in the natural/spontaneous postmenopausal (amenorrhea for at least 12 months) period for less than 10 years,
  • Having stable vital signs (heart rate, blood pressure),
  • Volunteer to participate in the study,
  • Have signed the informed consent form.

Exclusion Criteria

  • Neurological diseases,
  • Uncontrolled systemic and metabolic diseases (uncontrolled diabetes mellitus, hypertension, etc.)
  • History of cancer,
  • History of surgical menopause,
  • Obesity (BMI > 35 kg/m²),
  • Use of any hormonal or non-hormonal treatment for vasomotor or other menopausal symptoms in the past 6 months,
  • Psychiatric and mental disorders that prevent the cooperation to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connective tissue manipulation
Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group.
Other: Connective tissue manipulation
Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group.
Placebo Comparator: Superficial massage with the head of the therapeutic ultrasound device
Superficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group.
Other: Superficial massage with the head of the therapeutic ultrasound device
Superficial massage with the head of the therapeutic ultrasound device will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of vasomotor symptoms
Time Frame: Change in the frequency of vasomotor symptoms from baseline to at the end of the 4th week.
Frequency of hot flashes, sweating and night sweats will be assessed by daily diaries. Participants will record their hot flashes, sweating and night sweats during seven days at the baseline and just after the completion of the study.
Change in the frequency of vasomotor symptoms from baseline to at the end of the 4th week.
Vasomotor symptom intensity
Time Frame: Change in the vasomotor symptom score from baseline to at the end of the 4th week.
The vasomotor symptom intensity, which will be obtained by multiplying the frequency and severity (mild, moderate, severe) of hot flashes, sweating and night sweats assessed by daily diaries. Participants will record their hot flashes, sweating and night sweats during seven days at the baseline and just after the completion of the study.
Change in the vasomotor symptom score from baseline to at the end of the 4th week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of menopausal symptoms
Time Frame: Change in the severity of menopausal symptoms from baseline to at the end of the 4th week.
The severity of menopausal symptoms will be evaluated with the Menopause Rating Scale (MRS). MRS was developed to assess the severity of 11 symptoms associated with menopause. Each of the 11 symptoms may score between 0 (no symptoms) and 4 points (severe symptoms), depending on the perceived severity of the complaints. The total score of the MRS ranges between 0 (asymptomatic) and 44 (highest degree of complaints).
Change in the severity of menopausal symptoms from baseline to at the end of the 4th week.
Level of psychological symptoms
Time Frame: Change in the level of psychological symptoms from baseline to at the end of the 4th week.
The level of psychological symptoms will be evaluated with the Depression, Anxiety and Stress Scale-21 (DASS-21). DASS-21 is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Change in the level of psychological symptoms from baseline to at the end of the 4th week.
Severity of insomnia
Time Frame: Change in severity of insomnia from baseline to at the end of the 4th week.
Severity of insomnia will be evaluated with the Insomnia Severity Index (ISI). ISI is a seven-item, five-point Likert-type questionnaire to assess the severity of sleep disturbance during the past two weeks. Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity.
Change in severity of insomnia from baseline to at the end of the 4th week.
Quality of life associated with menopause
Time Frame: Change in quality of life associated with menopause from baseline to at the end of the 4th week.
Menopause-related quality of life will be assessed with the Menopause Specific Quality of Life Questionnaire (MENQOL). MENQOL was developed to determine how changes in the physical, psychological and social areas during the menopausal period affect the quality of life of women. The scale is an eight-point Likert-type scale and consists of 29 questions.
Change in quality of life associated with menopause from baseline to at the end of the 4th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Hitit University

Investigators

  • Principal Investigator: Serap Özgül, PhD, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 499

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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