The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Brief Summary: The aim of the present study is to investigate the efficacy of connective
      tissue massage in patients with primary dysmenorrhea. The present study is designed as a
      randomized placebo controlled study. Patients with primary dysmenorrhea and who agreed to
      participate in the study will be randomly divided into three groups. Connective tissue
      massage will be applied to the patients in the intervention group. Placebo ultrasound
      treatment will be applied to the patients in the placebo group. No application will be
      applied to the patients in the control group. As the research design includes the placebo
      group and the control group, it will be determined that if significant differences between
      the intervention and placebo groups are observed, this treatment effect is not related to a
      placebo effect or is not due to the natural course of the disease. If significant differences
      are found, the efficacy of the connective tissue manipulation in primary dysmenorrhea will be
      revealed and connective tissue manipulation may be an alternative approach to pharmacological
      approaches and other commonly used applications. This may reduce the need for pharmacological
      agents and reduce or eliminate the side effects associated with these agents.

      According to the literature, there are studies that investigate short-term effects of
      connective tissue massage on symptoms of primary dysmenorrhea and quality of life. However,
      there is no long-term follow-up randomized placebo-controlled study investigating the effect
      of connective tissue massage on menstrual pain and symptoms.
    

Detailed description: 
      Primary dysmenorrhea is defined as cramping pain in the lower abdomen that occurs before or
      during menstruation without identifiable pelvic pathology. Secondary symptoms include nausea,
      vomiting, fatigue, back pain, headaches, dizziness, and diarrhea. Primary dysmenorrhea has
      been reported as the leading cause of recurrent absenteeism from school or work in adolescent
      girls and young women, and it is considered to be a common disorder among women of
      reproductive age. The greater percentages of depression and anxiety are more common in
      patients with severe dysmenorrhea compared to those without dysmenorrhea. The prevalence of
      dysmenorrhea varies between 25-97%, and approximately 20% of them have severe pain.

      Treatment in primary dysmenorrhea can be classified as pharmacological, non-pharmacological
      and complementary therapies. Pharmacological therapies focus on the reduction of menstrual
      pain and relaxation of the uterine muscles with non-steroidal anti-inflammatory drugs
      (NSAIDs) or oral contraceptive pills. Management of dysmenorrhea with these pharmacological
      agents is associated with side effects such as nausea, breast tenderness, inter-menstrual
      bleeding and auditory and visual disturbances. Therefore, non-pharmacological approaches are
      needed in the treatment of dysmenorrhea. Non-pharmacological approaches to relieve
      dysmenorrhea symptoms include acupuncture, reflexology, biofeedback, transcutaneous
      electrical stimulation, relaxation therapy, massage therapy, and exercise. Complementary
      therapies include essential fatty acids, vitamins, herbal medicine, and aromatherapy. It has
      been known that previous studies investigating the efficacy of these approaches in primary
      dysmenorrhea do not have a control or placebo-control group or they reveal the effectiveness
      of combined applications.

      Connective tissue manipulation is a manually administered reflex therapy or a massage
      application. It may target superficial connective tissues and may stimulate segmental and
      supra-segmental autonomic cutaneous-visceral reflexes to restore autonomic balance and reduce
      dysfunction in affected internal organs. Therefore, connective tissue manipulation can be
      used to increase circulation of the uterus by stimulating segmental reflexes and to reduce
      congestion and menstrual pain. Although the effect of connective tissue massage on a wide
      range of health problems such as painful syndromes, vascular problems or bowel dysfunction is
      investigated, there is limited evidence of its use in primary dysmenorrhea. There is no
      randomized placebo-controlled study investigating the effects of connective tissue massage on
      menstrual pain and symptoms of dysmenorrhea. Therefore, the aim of the present study is to
      determine the effectiveness of connective tissue massage by the randomized placebo-controlled
      design in patients with primary dysmenorrhea.
    

Intervention name(s): connective tissue manipulation; placebo ultrasound
Intervention type(s): Other; Other
Intervention description(s): From the estimated date of ovulation to the onset of menstrual bleeding, connective tissue massage will be applied to the sacral, lumbar, lower thoracic and anterior pelvic regions for 5 days per week. The application will take 10 min. During the massage treatment, the physiotherapist will touch the end of the middle finger with the skin of the patient and apply the skin to the pull. The patient will be in the supine position during the treatment of the anterior pelvic region while the patient is in the sitting position during the treatment of the back area.; From the estimated date of ovulation to the beginning of the next menstrual bleeding, placebo ultrasound will be applied a total of 10 minutes (5 minutes for sacral and lumbar, and lower thoracic regions and 5 min for the anterior pelvic region). Placebo ultrasound application will be performed with superficial circular movements without applying excessive pressure. During the application, the device will only be switched on, the dose will not be adjusted and the patient will be given an image of ultrasound dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: connective tissue massage; massage; menstrual pain; treatment