- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05158036
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
Conditions
Intervention / Treatment
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Primary Dysmenorrhea
-
Ankara UniversityThe Scientific and Technological Research Council of TurkeyNot yet recruiting
-
University of SharjahNot yet recruiting
-
Cairo UniversityRecruitingPrimary DysmenorrheaEgypt
-
Cairo UniversityCompletedPrimary DysmenorrheaEgypt
-
Camilo Jose Cela UniversityNot yet recruiting
-
Cairo UniversityNot yet recruitingPrimary DysmenorrheaEgypt
-
Rana Salem Abdelghany AliCompletedPrimary DysmenorrheaEgypt
-
University of HailHealth Education Research Foundation (HERF)Recruiting
-
ApexCPG LLCNot yet recruitingPrimary Dysmenorrhea | Menstural CrampsIndia
-
University of California, DavisINCREDIWEAR HOLDINGS, INC.Not yet recruitingPrimary Dysmenorrhea | Women's Health | Menstrual Cramps | Primary Dysmenorrhea (PD)
Clinical Trials on Classic massage group
-
Okan UniversityNot yet recruiting
-
Ataturk Training and Research HospitalCompleted
-
University of ValenciaCompletedHamstring ContracturesSpain
-
Jagiellonian UniversityNot yet recruitingMassage | Asthma PatientsPoland
-
Jagiellonian UniversityCompletedMassage | SpirometryPoland
-
Halic UniversityActive, not recruitingCerebral Palsy | Chronic ConstipationTurkey
-
Luis Gustavo Lizi JorgeActive, not recruiting
-
Universidad de AlmeriaCompletedLow Back Pain | Musculoskeletal ManipulationsSpain
-
TC Erciyes UniversityCompleted