Primary Dysmenorrhea (PD)NCT07213336
A New Treatment for Primary Dysmenorrhea
A study testing Exercise, massage in people with Primary Dysmenorrhea (PD), run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Primary dysmenorrhea (PD) is a chronic health condition that affects primarily young women and interferes with daily activities, causes loss of work productivity, and reduces quality of life. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea (PD)
- What is being tested?
- Exercise, massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being a woman between the ages of 18 and 30
- Having a diagnosis of primary dysmenorrhea
- Not having given birth
- Having a regular menstrual cycle (28 ± 7 days)
Who cannot join
- Having been diagnosed with rheumatic, gastrointestinal, psychiatric, neurological diseases, or other chronic pain syndromes
- Being on any anti-inflammatory, analgesic, or estrogen/progestin pill (OCP) treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Trigger Point Massage and Stretching Exercises on Menstruation Symptoms, Pain Intensity and Quality of Life in Primary Dysmenorrhea
Primary dysmenorrhea (PD) is a chronic health condition that affects primarily young women and interferes with daily activities, causes loss of work productivity, and reduces quality of life. In this controlled study, the effects of trigger point massage and stretching exercises applied to patients diagnosed with primary dysmenorrhea on pain severity (Visual Analog Scale), menstrual symptoms (Menstruation Symptom Scale) and quality of life (SF-36) were investigated. Forty-five women who were followed up with the diagnosis of Primary Dysmenorrhea in the Gynecology and Obstetrics Clinic of a local Hospital. Participants were randomly assigned to exercise, exercise+trigger point, and control groups using a computer-generated randomization list. The "Visual Analog Scale" was used to evaluate the severity of menstrual pain, "Menstruation Symptom Scale" was used to evaluate the severity of menstrual symptoms, and "SF-36" was used to evaluate the quality of life.
Read the detailed description
This controlled experimental study included 45 volunteers diagnosed with primary dysmenorrhea by a gynecologist. Participants were randomly assigned to three groups using the "Research Randomizer" web program. The control group (n=14) received no intervention. The stretching exercise group (n=15) received only stretching exercises; the stretching and trigger point group (n=15) received stretching exercises plus trigger point massage of the quadratus lumborum, rectus abdominus, iliopsoas, and hip adductor muscles, all performed by the same trained physiotherapist.
Study Inclusion Criteria:
- Being a woman between the ages of 18 and 30,
- Having a diagnosis of primary dysmenorrhea,
- Being a nulliparous,
- Having a regular menstrual cycle (28 ± 7 days). Exclusion Criteria
- Having rheumatic, gastrointestinal, psychiatric, surgical, or other chronic pain syndromes;
- Being on any anti-inflammatory, analgesic, or non-convertible progestin pill (OCP) Participants in the control group were not included in the treatment program administered to the other participants for 8 weeks, but continued the NSAID medication prescribed by the doctor who diagnosed dysmenorrhea.
Participants in the stretching group underwent a 45-minute exercise program twice a week, accompanied by a physiotherapist, for 8 weeks. Participants in the stretching exercises and trigger point massage group underwent a 45-minute exercise program twice a week, accompanied by a physiotherapist, for 8 weeks.
- Conditions
- Primary Dysmenorrhea (PD)
- Being tested
- Exercise, massage
- Keywords
- Stretching exercises, menstrual pain, primary dysmenorrhea, trigger point massage
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, massageOther
trigger point massage and stretching exercise
| Study group | Role | What they receive |
|---|---|---|
| 1. group | No intervention | Control group |
| 2.group | Experimental | Stretching exercise group Receives: Other: Exercise, massage |
| 3.group | Experimental | trigger point massage and stretching exercise group Receives: Other: Exercise, massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36
SF-36: This questionnaire has 8 subscales, totaling 36 questions: 10 items on "physical function," 7 items on "role limitations due to physical (4 items) and emotional problems (3 items), 2 items on "pain," 4 items on "vitality," 2 items on "social function," 5 items on "mental health," and 5 items on "general health.
Measured: The 1st and 3rd Most Painful Days of the Menstrual Cycle
Visual Analog Scale
Visual Analog Scale: The visual analog scale (VAS) is the most commonly used tool for assessing pain intensity. It is easy to use, provides reproducible results, and can be applied to a variety of practice settings.
Measured: The 1st and 3rd Most Painful Days of the Menstrual Cycle
Personal Information Form
Personal Information Form: This form includes personal information.
Measured: The 1st and 3rd Most Painful Days of the Menstrual Cycle
menstrual symptom scale
It consists of a 5-point Likert-type scale with a total of 24 items. Individuals are asked to rate their menstruation-related symptoms between 1 (never) and 5 (always). The MBI score is calculated by averaging the total scores of the scale items. A higher mean score indicates an increased severity of menstrual symptoms.
Measured: The 1st and 3rd Most Painful Days of the Menstrual Cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Dec 2022
- Primary completion1 Feb 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep İrem Kar, Halic University
- Investigators
- melek g yavuzer, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213336
- Sponsor's protocol ID
- HalicU-FTR-ZİK-01
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want it to be shared without being published in any journal.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trigger Point Massage and Stretching Exercises on Menstruation Symptoms, Pain Intensity and Quality of Life in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07213336
- Acronym / sponsor ID
- HalicU-FTR-ZİK-01
- Conditions
- Primary Dysmenorrhea (PD)
- Keywords
- Stretching exercises, menstrual pain, primary dysmenorrhea, trigger point massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary dysmenorrhea (PD) is a chronic health condition that affects primarily young women and interferes with daily activities, causes loss of work productivity, and reduces quality of life. In this controlled study, the effects of trigger point massage and stretching exercises applied to patients diagnosed with primary dysmenorrhea on pain severity (Visual Analog Scale), menstrual symptoms (Menstruation Symptom Scale) and quality of life (SF-36) were investigated. Forty-five women who were followed up with the diagnosis of Primary Dysmenorrhea in the Gynecology and Obstetrics Clinic of a local Hospital. Participants were randomly assigned to exercise, exercise+trigger point, and control groups using a computer-generated randomization list. The "Visual Analog Scale" was used to evaluate the severity of menstrual pain, "Menstruation Symptom Scale" was used to evaluate the severity of menstrual symptoms, and "SF-36" was used to evaluate the quality of life.
Detailed description
This controlled experimental study included 45 volunteers diagnosed with primary dysmenorrhea by a gynecologist. Participants were randomly assigned to three groups using the "Research Randomizer" web program. The control group (n=14) received no intervention. The stretching exercise group (n=15) received only stretching exercises; the stretching and trigger point group (n=15) received stretching exercises plus trigger point massage of the quadratus lumborum, rectus abdominus, iliopsoas, and hip adductor muscles, all performed by the same trained physiotherapist.
Study Inclusion Criteria:
- Being a woman between the ages of 18 and 30,
- Having a diagnosis of primary dysmenorrhea,
- Being a nulliparous,
- Having a regular menstrual cycle (28 ± 7 days). Exclusion Criteria
- Having rheumatic, gastrointestinal, psychiatric, surgical, or other chronic pain syndromes;
- Being on any anti-inflammatory, analgesic, or non-convertible progestin pill (OCP) Participants in the control group were not included in the treatment program administered to the other participants for 8 weeks, but continued the NSAID medication prescribed by the doctor who diagnosed dysmenorrhea.
Participants in the stretching group underwent a 45-minute exercise program twice a week, accompanied by a physiotherapist, for 8 weeks. Participants in the stretching exercises and trigger point massage group underwent a 45-minute exercise program twice a week, accompanied by a physiotherapist, for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. group | No intervention | –Control group |
| 2.group | Experimental | Other: Exercise, massageStretching exercise group |
| 3.group | Experimental | Other: Exercise, massagetrigger point massage and stretching exercise group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a woman between the ages of 18 and 30
- Having a diagnosis of primary dysmenorrhea
- Not having given birth
- Having a regular menstrual cycle (28 ± 7 days)
Key exclusion criteria (2 listed)
- Having been diagnosed with rheumatic, gastrointestinal, psychiatric, neurological diseases, or other chronic pain syndromes
- Being on any anti-inflammatory, analgesic, or estrogen/progestin pill (OCP) treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise, massagetrigger point massage and stretching exercise | Other | 2.group, 3.group |
Primary outcome
SF-36
Time frame: The 1st and 3rd Most Painful Days of the Menstrual Cycle
SF-36: This questionnaire has 8 subscales, totaling 36 questions: 10 items on "physical function," 7 items on "role limitations due to physical (4 items) and emotional problems (3 items), 2 items on "pain," 4 items on "vitality," 2 items on "social function," 5 items on "mental health," and 5 items on "general health.
Visual Analog Scale
Time frame: The 1st and 3rd Most Painful Days of the Menstrual Cycle
Visual Analog Scale: The visual analog scale (VAS) is the most commonly used tool for assessing pain intensity. It is easy to use, provides reproducible results, and can be applied to a variety of practice settings.
Personal Information Form
Time frame: The 1st and 3rd Most Painful Days of the Menstrual Cycle
Personal Information Form: This form includes personal information.
menstrual symptom scale
Time frame: The 1st and 3rd Most Painful Days of the Menstrual Cycle
It consists of a 5-point Likert-type scale with a total of 24 items. Individuals are asked to rate their menstruation-related symptoms between 1 (never) and 5 (always). The MBI score is calculated by averaging the total scores of the scale items. A higher mean score indicates an increased severity of menstrual symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No. I do not want it to be shared without being published in any journal.
Related trials for Primary Dysmenorrhea (PD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
melek g yavuzer study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, massage in people with Primary Dysmenorrhea (PD), run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 (time frame: The 1st and 3rd Most Painful Days of the Menstrual Cycle). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.