Effects of Connective Tissue Manipulation on Menopausal Symptoms
Condition: Menopause Syndrome
Study type: Interventional

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 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: 
      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.
    

Intervention name(s): Connective tissue manipulation; Superficial massage with the head of the therapeutic ultrasound device
Intervention type(s): Other; Other
Intervention description(s): 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 will be applied to participants' back for 15 minutes, 3 times a week for 4 weeks in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Vasomotor symptom; Massage; Connective tissue massage; Connective tissue manipulation; Physiotherapy