Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea

December 2, 2021 updated by: Seyda TOPRAK CELENAY, Ataturk Training and Research Hospital
The aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD.

Study Overview

Status

Not yet recruiting

Detailed Description

Primary dysmenorrhea is defined as painful menstrual cramps without an underlying pelvic pathology or organic problem. Massage, which is one of the physiotherapy methods that reduces pain by acting on the autonomic nervous system and circulation, has an important place in the management of PD among non-pharmacological treatment approaches. In the literature, there are studies on the use of classical massage and connective tissue massage in women with PD for reducing menstrual pain and PD-related symptoms. However, to the best of our knowledge, no study has been found comparing classical massage and connective tissue massage in PD management.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Over 18 years of age
  • Women with a complaint of primary dysmenorrhea,
  • Volunteer women who have a regular menstrual cycle (28 ± 7 days)
  • Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months

Exclusion Criteria:

  • Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes,
  • Those who have given birth,
  • Those who have a pregnancy status,
  • Those who use intrauterine devices,
  • Those who have had pelvic surgery,
  • Those who use chronic medications, including oral contraceptives or antidepressants, for at least 6 months before the study,
  • Those with a pathological history and radiological findings showing secondary dysmenorrhea

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Classic massage group
Classical massage will be applied to the lumbal and abdominal region 5 days a week, from the estimated date of ovulation until the next menstrual bleeding begins. The application will take approximately 15 minutes. During the massage, the physiotherapist will apply stroking and kneading movements by using baby oil. During the treatment of the lumbal region, the patient will be in the prone position; during the treatment of the abdominal region, the patient will be in the supine position.
Classic massage application will be given to the Classic massage group
Active Comparator: Connective tissue massage group
Connective tissue massage will be applied to the lumbosacral, lower thoracic, abdominal and anterior pelvic regions 5 days a week, from the estimated date of ovulation until the onset of the next menstrual bleeding. The application will take approximately 15 minutes. During the massage, the physiotherapist will bring the tip of the middle finger of the hand into contact with the patient's skin and apply traction to the skin. During the treatment of the lumbar region, the patient will be in the sitting position, during the treatment of the abdominal and anterior pelvic region, the patient will be in the supine position.
Connective tissue masage application will be given to the Connective tissue masage group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: change from baseline at an average of 2 weeks
Menstrual pain intensity will be evaluated with Visual Analogue Scale.
change from baseline at an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold
Time Frame: change from baseline at an average of 2 weeks
Pressure pain threshold will be evaluated with algometer
change from baseline at an average of 2 weeks
Primary dysmenorrhea (PD)-related symptoms
Time Frame: change from baseline at an average of 2 weeks
Severity of PD-related symptoms will be evaluated Visual Analogue Scale.
change from baseline at an average of 2 weeks
Functional and emotional effects
Time Frame: change from baseline at an average of 2 weeks
Functional and emotional effects will be evaluated with Functional and Emotional Dysmenorrhea Scale.
change from baseline at an average of 2 weeks

Collaborators and Investigators

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

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 (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2021/12/01

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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