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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Classic massage group
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.
Other: Connective tissue masage
Connective tissue masage application will be given to the Connective tissue masage group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk Training and Research Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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