Effects of Connective Tissue Manipulation on Menopausal Symptoms

Not Applicable

Completed

• Conditions: Menopause Syndrome
• Interventions: Other: Connective tissue manipulation; Other: Superficial massage with the head of the therapeutic ultrasound device

• Registration Number: NCT05293860
• Lead Sponsor: Hacettepe University

Brief Summary

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 CTM on postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.

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 outcome is menopausal symptom severity and will be assessed by the "Menopause Rating Scale". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires; "Menopause-Specific Quality of Life Scale", "Depression-Anxiety-Stress 21 Scale" and "Insomnia Severity Index". 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

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 postmenopausal symptoms, menopause-specific quality of life (MENQoL) and insomnia.

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 outcome is menopausal symptom severity and it will be evaluated by "Menopause Rating Scale". Secondary outcomes are hot flash frequency, hot flash score (frequency X severity), menopause-specific quality of life, emotional status and insomnia. These outcomes will be assessed by daily diaries and the questionnaires "Menopause-Specific Quality of Life Scale", "Depression-Anxiety-Stress 21 Scale" and "Insomnia Severity Index".

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-24
• Study Start: 2022-04-15
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Connective tissue manipulation	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.
Superficial massage with the head of the therapeutic ultrasound device	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.

Primary Outcome Measures

Name	Time	Method
Severity of menopausal symptoms	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).

Secondary Outcome Measures

Name	Time	Method
Vasomotor symptom intensity	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.
Quality of life associated with menopause	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.
Frequency of vasomotor symptoms	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.
Level of psychological symptoms	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.
Severity of insomnia	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey