Effects of Connective Tissue Manipulation on Menopausal Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Connective Tissue Manipulation on Menopausal Symptoms

Conditions
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Menopause Syndrome

Intervention / Treatment
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* Other: Connective tissue manipulation
* Other: Superficial massage with the head of the therapeutic ultrasound device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of vasomotor symptoms | 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 | 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 | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Vasomotor symptom, Massage, Connective tissue massage, Connective tissue manipulation, Physiotherapy