Effects of Connective Tissue Manipulation on Menopausal Symptoms

Hacettepe University

Status: Completed

Conditions: Menopause Syndrome

Treatments: Other: Superficial massage with the head of the therapeutic ultrasound device; Other: Connective tissue manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05293860

499

Details and patient eligibility

About

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 sham 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 sham 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.

Full 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 sham 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 sham 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.

Enrollment: 52 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Connective tissue manipulation

Experimental group

Description:

Connective tissue manipulation will be applied to participants' back for 5-20 minutes, 3 times a week for 4 weeks in this group.

Treatment:

Other: Connective tissue manipulation

Superficial massage with the head of the therapeutic ultrasound device

Sham Comparator group

Description:

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.

Treatment:

Other: Superficial massage with the head of the therapeutic ultrasound device