The Effects of Connective Tissue Manipulation in Primary Dysmenorrhea

November 20, 2021 updated by: SERAP ÖZGÜL, Hacettepe University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 9000
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline pain intensity to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 state and trait anxiety scales range between 20-80. Higher scores indicate higher anxiety level.
change from baseline anxiety level to 6 months
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.
change from baseline psychological status to 6 months
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.
change from baseline self-reported improvement to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Ceren Gursen, Hacettepe University, Ankara, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 20, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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