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The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea

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ClinicalTrials.gov Identifier: NCT03914014
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ceren Orhan, Hacettepe University

Brief 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.


Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Other: connective tissue manipulation Other: placebo ultrasound Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Active Comparator: intervention
connective tissue manipulation
Other: connective tissue manipulation
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.

Placebo Comparator: placebo ultrasound
placebo ultrasound
Other: placebo ultrasound
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.

No Intervention: control
control group



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: change from baseline pain intensity to 6 months ]
    Pain intensity will be assessed by 0-10 cm Visual Analogue Scale. The score ranges between 0 and 10. Higher scores indicate higher pain intensity.


Secondary Outcome Measures :
  1. Anxiety level [ Time Frame: change from baseline anxiety level to 6 months ]
    Anxiety level will be assessed with the State-Trait Anxiety Inventory (STAI). The STAI consists of two scale (state anxiety scale and trait anxiety scale) to measure the state and trait anxiety levels separately. Therefore, two scores are obtained from the STAI for the state and trait anxiety levels. The scores of stait and trait anxiety scales range between 20-80. Higher scores indicate higher anxiety level.

  2. Psychological status [ Time Frame: change from baseline psychological status to 6 months ]
    Psychological status will be evaluated by the Beck Depression Inventory (BDI). The BDI consists of 21 questions. The total score of BDI ranges from 0 to 63. The greater scores on the BDI demonstrates more severe depressive symptoms.

  3. Self-reported improvement [ Time Frame: change from baseline self-reported improvement to 6 months ]
    Self-reported improvement will be evaluated by the 7-point Likert type scale. The items of this scale are as follows: 1) much much better, 2) much better, 3) a little better, 4) no change, 5) a little worse, 6) much worse, and 7) much much worse. The total score ranges between 1 and 7. Greater scores indicate lower perception of self-reported improvement.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being volunteer to participate in the study
  • Having regular menstrual cycles (28 ± 7 days)
  • Being nulliparous
  • Having history of the onset of menstrual pain in the first few years after menarche
  • Considering the last 6 months, pain intensity >4 on the Visual Analog Scale.

Exclusion Criteria:

  • Severe gastrointestinal, urogynecologic or autoimmune disease, other chronic pain syndromes, psychiatric disorder
  • Pregnancy
  • Use of intrauterine device
  • Use of pharmacologic agents (except analgesics or non-NSAID) or non-pharmacological agent
  • Urogynecological surgery
  • Oral contraceptive or antidepressant use during the last 6 months
  • Having an irregular menstrual cycle
  • Endometriosis associated with suspected dysmenorrhea, pathologic condition associated with uterine pain such as fibroids, or ultrasonographic examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914014


Contacts
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Contact: Serap Kaya +905339390803 serapky@yahoo.com
Contact: Ceren Orhan +905380644120 cerengursen@yahoo.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey, 9000
Contact: Ceren Orhan, MS    +905380644120    cerengursen@yahoo.com   
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Ceren Orhan Hacettepe University, Ankara, Turkey

Publications of Results:
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Responsible Party: Ceren Orhan, Principal investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03914014     History of Changes
Other Study ID Numbers: 2018-158
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ceren Orhan, Hacettepe University:
connective tissue massage
massage
menstrual pain
treatment

Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms