Dysmenorrhea PrimaryNCT06492148
Myofascial Release Technique in Women With Primary Dysmenorrhea
A study testing Myofascial Release in people with Dysmenorrhea Primary and Central Sensitisation, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
It has been found that women with dysmenorrhea have active trigger points, particularly in the rectus abdominis, oblique abdominal muscles, quadratus lumborum, and paraspinal muscles. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea Primary, Central Sensitisation, Myofascial Trigger Point Pain
- What is being tested?
- Myofascial Release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide,
- Having regular menstruation in the last 6 months (28±7 days)
- Those who had menstrual pain between 40 mm and 100 mm according to the Visual Analogue Scale (VAS) in the last 6 months
Who cannot join
- Diagnosed with Secondary Dysmenorrhea,
- Having given birth,
- Those with serious gastrointestinal, urogynecological, or autoimmune diseases or other chronic pain syndromes,
- Undergoing urogynecological surgery,
- Those who are pregnant or suspected of pregnancy,
- Those who use analgesics or non-pharmacological agents other than NSAIDs for menstrual pain,
- Those using intrauterine or oral contraceptives,
- Those taking extra supplements such as magnesium, which may affect treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University
Ankara, 06530
Beyza Yazgan Dagli, beyzayazgan@gazi.edu.tr
Beyza Yazgan Dagli
About this study
Official title: Effect of Myofascial Release Technique on Central Sensitization, Myofascial Trigger Point and Menstrual Symptoms in Women With Primary Dysmenorrhea: Sham-Controlled, Randomized Double-Blind Study
It has been found that women with dysmenorrhea have active trigger points, particularly in the rectus abdominis, oblique abdominal muscles, quadratus lumborum, and paraspinal muscles. The myofascial release technique is a widely used manual therapy method characterized by the application of low-load, long-duration mechanical forces to manipulate the myofascial complex. This technique aims to restore optimal length, alleviate pain, and improve function. This study aims to examine the effect of the myofascial release technique on central sensitization, myofascial trigger points, and menstrual symptoms in women with primary dysmenorrhea.
Read the detailed description
During the evaluation period, the participants' musculoskeletal pain threshold and tolerance will be measured using an algometer, about trigger points on the identified muscles (rectus abdominis, quadratus lumborum, erector spinae, and tibialis anterior). A total of 40 women, aged 18-40, diagnosed with primary dysmenorrhea by a gynecologist, will be included in the study. The initial assessment of the participants will be conducted on their most painful days. Participants will be randomized into two groups: the myofascial release technique group (study group) and the placebo myofascial release technique group (control group). The interventions will be conducted over 10 sessions during one menstrual cycle, and all evaluations will be repeated after the treatment period. The study will be conducted as a double-blind trial, ensuring that both the evaluators and the patients are blind to the group assignments.
- Conditions
- Dysmenorrhea Primary, Central Sensitisation, Myofascial Trigger Point Pain, Menstrual Discomfort, Myofascial Release
- Being tested
- Myofascial Release, Sham-Myofascial Release
- Keywords
- myofascial release, trigger point, Central sensitization, Dysmenorrhea, sham
- Medical subject headings
- Myofascial Pain Syndromes, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial ReleaseOther
The myofascial release technique is a widely used manual therapy method characterized by low-load, prolonged mechanical forces applied to manipulate the myofascial complex, aiming to restore optimal length, alleviate pain, and improve function.
Sham-Myofascial ReleaseOther
The hands of the researcher applying the technique will be placed in the same areas as the myofascial release technique, with only the palms in light contact for the same duration. However, no intervention will be made to create any pressure or open the tissue barrier.
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Release Group | Active comparator | The technique known as myofascial release, also referred to as cross-hand release, will be applied to 7 regions. Among these regions are the lateral abdominal wall (right and left), the lower abdomen with the opposite side medial thigh (right and left crossed), the thoracolumbar fascia (bilateral), and the lumbosacral region. In the cross-hand technique, hands will be gently placed on the specified regions and directions. The release of the barriers of the tissue under the hands will be ensured, and the technique will be applied until a wave or oscillation is felt. A myofascial release technique with an optimal duration of 5 minutes will be applied to each region. The total treatment time will be 35 minutes. Receives: Other: Myofascial Release |
| Sham- Myofascial Release Group | Sham comparator | The hands of the researcher applying the technique will be positioned on the same regions as the myofascial release technique, with only the palms lightly touching for the same duration. However, there will be no intervention aimed at applying pressure or opening tissue barriers. The total sham treatment time will be 35 minutes. Receives: Other: Sham-Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Threshold
Trigger points in specific muscles (rectus abdominis, paraspinal muscles, quadratus lumborum, gluteus maximus) will be determined. Then, it will be applied to the trigger points with the Baseline brand algometer in accordance with standard procedures and the pressure will be increased by 30 kPa/s.
Measured: Baseline (First menstruation cycle)
Pain Pressure Threshold
Trigger points in specific muscles (rectus abdominis, paraspinal muscles, quadratus lumborum, gluteus maximus) will be determined. Then, it will be applied to the trigger points with the Baseline brand algometer in accordance with standard procedures and the pressure will be increased by 30 kPa/s.
Measured: through study completion, an average of 3 months
Central Sensitization
Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
Measured: Baseline (First menstruation cycle)
Central Sensitization
Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
Measured: through study completion, an average of 3 months
Menstrual pain intensity
Menstrual pain intensity will be determined by a 10 cm Visual Analog Scale ranging from zero (no pain at all) to 10 (worst pain I have ever felt). Higher scores mean worse conditions. Participants will be asked to mark the severity of pain they felt in the first 3 days of their last menstrual bleeding on 3 separate lines.
Measured: Baseline (First menstruation cycle)
Menstrual pain intensity
Menstrual pain intensity will be determined by a 10 cm Visual Analog Scale ranging from zero (no pain at all) to 10 (worst pain I have ever felt). Higher scores mean worse conditions. Participants will be asked to mark the severity of pain they felt in the first 3 days of their last menstrual bleeding on 3 separate lines.
Measured: through study completion, an average of 3 months
Secondary outcomes (8)
Menstrual Attitude
Menstrual Attitude Scale will be used to evaluate symptoms related to menstruation. High scores indicate a high awareness of menstruation.
Measured: Baseline (First menstruation cycle)
Menstrual Attitude
Menstrual Attitude Scale will be used to evaluate symptoms related to menstruation. High scores indicate a high awareness of menstruation.
Measured: through study completion, an average of 3 months
Health-related quality of life
Short Form (SF-36) will be used to evaluate individuals' general health-related quality of life. SF-36 is a 36-question survey that evaluates functionality and well-being and consists of 8 subscales. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Higher scores indicate a better quality of life.
Measured: Baseline (First menstruation cycle)
Health-related quality of life
SF-36 will be used to evaluate individuals' general health-related quality of life. SF-36 is a 36-question survey that evaluates functionality and well-being and consists of 8 subscales. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Higher scores indicate a better quality of life.
Measured: through study completion, an average of 3 months
Anxiety
State and Trait Anxiety Scale is a self-assessment inventory that evaluates anxiety and consists of 40 items.
Measured: Baseline (First menstruation cycle)
Anxiety
State and Trait Anxiety Scale is a self-assessment inventory that evaluates anxiety and consists of 40 items.
Measured: through study completion, an average of 3 months
The Body Awareness
The Body Awareness Questionnaire will be used to evaluate changes in individuals' body awareness. The questionnaire consists of 18 items and 4 subscales (predicting body reactions, sleep-wake cycle, predicting the onset of the disease, paying attention to changes in body processes).
Measured: Baseline (First menstruation cycle)
The Body Awareness
The Body Awareness Questionnaire will be used to evaluate changes in individuals' body awareness. The questionnaire consists of 18 items and 4 subscales (predicting body reactions, sleep-wake cycle, predicting the onset of the disease, paying attention to changes in body processes).
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start10 Sep 2024
- Primary completion2 Dec 2024 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BEYZA YAZGAN DAĞLI, Gazi University
- Investigators
- Beyza Yazgan Dagli, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492148
- Sponsor's protocol ID
- 2023 - 1577
- Status last verified
- Nov 2024
- First submitted
- 11 Jun 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release Technique on Central Sensitization, Myofascial Trigger Point and Menstrual Symptoms in Women With Primary Dysmenorrhea: Sham-Controlled, Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT06492148
- Acronym / sponsor ID
- 2023 - 1577
- Conditions
- Dysmenorrhea Primary, Central Sensitisation, Myofascial Trigger Point Pain, Menstrual Discomfort, Myofascial Release
- Keywords
- myofascial release, trigger point, Central sensitization, Dysmenorrhea, sham
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
It has been found that women with dysmenorrhea have active trigger points, particularly in the rectus abdominis, oblique abdominal muscles, quadratus lumborum, and paraspinal muscles. The myofascial release technique is a widely used manual therapy method characterized by the application of low-load, long-duration mechanical forces to manipulate the myofascial complex. This technique aims to restore optimal length, alleviate pain, and improve function. This study aims to examine the effect of the myofascial release technique on central sensitization, myofascial trigger points, and menstrual symptoms in women with primary dysmenorrhea.
Detailed description
During the evaluation period, the participants' musculoskeletal pain threshold and tolerance will be measured using an algometer, about trigger points on the identified muscles (rectus abdominis, quadratus lumborum, erector spinae, and tibialis anterior). A total of 40 women, aged 18-40, diagnosed with primary dysmenorrhea by a gynecologist, will be included in the study. The initial assessment of the participants will be conducted on their most painful days. Participants will be randomized into two groups: the myofascial release technique group (study group) and the placebo myofascial release technique group (control group). The interventions will be conducted over 10 sessions during one menstrual cycle, and all evaluations will be repeated after the treatment period. The study will be conducted as a double-blind trial, ensuring that both the evaluators and the patients are blind to the group assignments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myofascial Release Group | Active comparator | Other: Myofascial ReleaseThe technique known as myofascial release, also referred to as cross-hand release, will be applied to 7 regions. Among these regions are the lateral abdominal wall (right and left), the lower abdomen with the opposite side medial thigh (right and left crossed), the thoracolumbar fascia (bilateral), and the lumbosacral region. In the cross-hand technique, hands will be gently placed on the specified regions and directions. The release of the barriers of the tissue under the hands will be ensured, and the technique will be applied until a wave or oscillation is felt. A myofascial release technique with an optimal duration of 5 minutes will be applied to each region. The total treatment time will be 35 minutes. |
| Sham- Myofascial Release Group | Sham comparator | Other: Sham-Myofascial ReleaseThe hands of the researcher applying the technique will be positioned on the same regions as the myofascial release technique, with only the palms lightly touching for the same duration. However, there will be no intervention aimed at applying pressure or opening tissue barriers. The total sham treatment time will be 35 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide,
- Having regular menstruation in the last 6 months (28±7 days)
- Those who had menstrual pain between 40 mm and 100 mm according to the Visual Analogue Scale (VAS) in the last 6 months
Key exclusion criteria (8 listed)
- Diagnosed with Secondary Dysmenorrhea,
- Having given birth,
- Those with serious gastrointestinal, urogynecological, or autoimmune diseases or other chronic pain syndromes,
- Undergoing urogynecological surgery,
- Those who are pregnant or suspected of pregnancy,
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 |
|---|---|---|
| Myofascial ReleaseThe myofascial release technique is a widely used manual therapy method characterized by low-load, prolonged mechanical forces applied to manipulate the myofascial complex, aiming to restore optimal length, alleviate pain, and improve function. | Other | Myofascial Release Group |
| Sham-Myofascial ReleaseThe hands of the researcher applying the technique will be placed in the same areas as the myofascial release technique, with only the palms in light contact for the same duration. However, no intervention will be made to create any pressure or open the tissue barrier. | Other | Sham- Myofascial Release Group |
Primary outcome
Pain Pressure Threshold
Time frame: Baseline (First menstruation cycle)
Trigger points in specific muscles (rectus abdominis, paraspinal muscles, quadratus lumborum, gluteus maximus) will be determined. Then, it will be applied to the trigger points with the Baseline brand algometer in accordance with standard procedures and the pressure will be increased by 30 kPa/s.
Pain Pressure Threshold
Time frame: through study completion, an average of 3 months
Trigger points in specific muscles (rectus abdominis, paraspinal muscles, quadratus lumborum, gluteus maximus) will be determined. Then, it will be applied to the trigger points with the Baseline brand algometer in accordance with standard procedures and the pressure will be increased by 30 kPa/s.
Central Sensitization
Time frame: Baseline (First menstruation cycle)
Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
Central Sensitization
Time frame: through study completion, an average of 3 months
Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
Menstrual pain intensity
Time frame: Baseline (First menstruation cycle)
Menstrual pain intensity will be determined by a 10 cm Visual Analog Scale ranging from zero (no pain at all) to 10 (worst pain I have ever felt). Higher scores mean worse conditions. Participants will be asked to mark the severity of pain they felt in the first 3 days of their last menstrual bleeding on 3 separate lines.
Menstrual pain intensity
Time frame: through study completion, an average of 3 months
Menstrual pain intensity will be determined by a 10 cm Visual Analog Scale ranging from zero (no pain at all) to 10 (worst pain I have ever felt). Higher scores mean worse conditions. Participants will be asked to mark the severity of pain they felt in the first 3 days of their last menstrual bleeding on 3 separate lines.
8 secondary outcomes
Menstrual Attitude
Time frame: Baseline (First menstruation cycle)
Menstrual Attitude
Time frame: through study completion, an average of 3 months
Health-related quality of life
Time frame: Baseline (First menstruation cycle)
Health-related quality of life
Time frame: through study completion, an average of 3 months
Anxiety
Time frame: Baseline (First menstruation cycle)
Anxiety
Time frame: through study completion, an average of 3 months
The Body Awareness
Time frame: Baseline (First menstruation cycle)
The Body Awareness
Time frame: through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Beyza Yazgan Dagli principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Release in people with Dysmenorrhea Primary and Central Sensitisation, run by Gazi 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Asisstant (+905535134631, beyzayazgan@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Pressure Threshold (time frame: Baseline (First menstruation cycle)). The study lists 6 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 21 Nov 2024.