Primary DysmenorrheaNCT06744608
Effectiveness of Structured Myofascial Release
A study testing Structured Myofascial Release, tens (transcutaneous electrical nerve stimulation) and lifestyle changes in people with Primary Dysmenorrhea, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our research is to examine the effects of myofascial release techniques on symptoms in patients with primary dysmenorrhea. With this research, we aim to improve the clinical symptoms, pain and tension of primary dysmenorrhea with a structured manual therapy consisting of myofascial release and sacral… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Structured Myofascial Release, tens (transcutaneous electrical nerve stimulation) and lifestyle changes
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2023to 16 Dec 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary dysmenorrhea diagnosed by a specialist gynecologist with 'Ultrasonography',
- Complaints of pain and spasm in the first 2 days of the menstrual cycle,
- Being two or above on the Weissmann scale,
- Being between the ages of 18-30,
- Volunteering to participate in the study
Who cannot join
- Having pelvic pathology,
- Having a history of previous pregnancy,
- Using a medication that causes or affects dysmenorrhea,
- Being pregnant,
- Using intrauterine or oral contraceptives,
- Having a Body Mass Index (BMI) of 30 and above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Structured Myofascial Release in the Treatment of Primary Dysmenorrhea
The aim of our research is to examine the effects of myofascial release techniques on symptoms in patients with primary dysmenorrhea. With this research, we aim to improve the clinical symptoms, pain and tension of primary dysmenorrhea with a structured manual therapy consisting of myofascial release and sacral mobilization in individuals with primary dysmenorrhea and an educational program that includes changes in daily life. Can Structured Myofascial Release Techniques Reduce Pain and Other Symptoms in Primary Dysmenorrhea? H0: Myofascial release techniques applied to individuals with primary dysmenorrhea have no effect on symptoms. H1: Myofascial release techniques applied to individuals with primary dysmenorrhea have an effect on symptoms.
Read the detailed description
Although primary dysmenorrhea is a common problem, especially among young women, there is generally no approach aimed at solving the main issue apart from symptomatic treatment or medication. Due to the side effects of medical treatments, many patients tend to opt for cheaper, non-medical, and non-aggressive methods.
The Weissman scale is scored between 0 and 3, where:
0: No dysmenorrhea
- Minimal (Able to work but feels discomfort)
- Moderate (Able to work but feels significant discomfort)
- Severe (Unable to work, bedridden) According to the Weissman scale, women in groups 1 and 2 continue with their daily lives or work/school but experience significant declines in their quality of life. On the other hand, individuals in group 3 suffer from work loss. Primary dysmenorrhea is associated with a significant economic burden caused by absenteeism and 2 to 3 times higher healthcare costs. Considering this cycle repeats in every menstrual period, a treatment approach is needed not only to alleviate symptoms but also to address the pathophysiological mechanisms of dysmenorrhea. The aim is to reduce elevated prostaglandin levels, decrease increased uterine contractions, relieve ischemia, and improve blood flow using structured myofascial release techniques.
Structured Myofascial Release Techniques
Myofascial release techniques involve manual physiotherapy administered by a physiotherapist to eliminate myofascial trigger points, reduce muscle tension, and alleviate associated pain. Structured myofascial release techniques aim to:
Provide relaxation in smooth muscles and ligaments through direct techniques to reduce increased uterine contractions.
Achieve neural relaxation via sacral mobilization. Incorporate a dual relaxation protocol involving both mechanical correction and stimulation of the parasympathetic nervous system.
It is thought that applying these two methods together increases the likelihood of treatment success. In 2022, a study demonstrated that myofascial release provided more effective relaxation and symptom reduction compared to pelvic floor exercises in patients with primary dysmenorrhea. This project aims to evaluate the effectiveness of myofascial release techniques and investigate whether the treatment effect persists after the intervention.
TENS (transcutaneous electrical nerve stimulation)
In the TENS group, pain is reduced by direct application to the lower abdominal area through the gate control theory. TENS is hypothesized to have two effects:
Elevating the threshold of pain signals caused by uterine hypoxia and hypercontractility by sending afferent impulses via the large-diameter sensory fibers of the same nerve root, thereby reducing the perception of painful uterine signals.
Stimulating endorphin release from peripheral nerves and the spinal cord Research Question and Hypotheses Research Question: Can structured myofascial release techniques reduce pain and other symptoms in the treatment of primary dysmenorrhea?
H0: Myofascial release techniques have no effect on the symptoms of individuals with primary dysmenorrhea.
H1: Myofascial release techniques have an effect on the symptoms of individuals with primary dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Structured Myofascial Release, tens (transcutaneous electrical nerve stimulation), lifestyle changes
- Keywords
- Myofascial Release, TENS (transcutaneous electrical nerve stimulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Myofascial ReleaseOther
haftada 2 seans 8 hafta boyunca toplam 16 seans uygulama yapıldı
tens (transcutaneous electrical nerve stimulation)Device
A total of 16 sessions of application were applied to the groups, 2 sessions per week for 8 weeks.
lifestyle changesBehavioural
A presentation including lifestyle changes was prepared and training was provided.
| Study group | Role | What they receive |
|---|---|---|
| Structured Myofascial Release | Active comparator | The treatment program consisting of myofascial release techniques includes the following applications; 1. Anterolateral abdominal wall release (Until relaxation is felt); Along the fundus of the uterus, along the ovaries and the broad ligament of the uterus, combined mobilization with rotation of the uterus and hips in the supine position and sacral mobilization for three minutes. Myofascial release was started by placing the fingers/dorsal side of the hand on the fascia. Pressure was applied on the soft tissue. After the restricted layer was felt, the fascia was moved along the surface while in contact with the lower layers. The technique was applied for an average of 60-90 seconds, but if necessary, it was continued until relaxation was felt. Receives: Other: Structured Myofascial Release |
| TENS (transcutaneous electrical nerve stimulation) | Active comparator | The TENS (transcutaneous electrical nerve stimulation) treatment program was applied by a physiotherapist using two 50X50 mm electrodes on the lower abdomen using conventional TENS at 200 μs, 100 Hz, and 30 min.
. Receives: Device: tens (transcutaneous electrical nerve stimulation) |
| lifestyle changes | Active comparator | Within the scope of education including lifestyle changes; Good nutrition. (what to take and what to avoid), supplements, relaxation training, meditation, exercise recommendations, avoiding tobacco smoke, warm showers, quality sleep (at least 6-8 hours), wearing comfortable clothes are included in the recommendations. Receives: Behavioral: lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
McGILL Pain Scale Short Form
The McGill pain questionnaire consists of four sections. In the first section, the individual marks the location of the pain on the body diagram and determines whether the pain comes from deep or superficial. In the second section, there are 20 word groups that examine pain in terms of sensory, perceptual and evaluative aspects. The individual is asked to select a set of words that fit their pain and mark the word that fits their pain within the selected set. The third section includes the relationship between pain and time. In the fourth section, five word groups ranging from "mild" pain to "unbearable" pain are defined to determine the severity of pain. The McGill Pain Questionnaire determines the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of pain that can be experienced by the individual. A high score indicates high level pain.
Measured: three mounth
Secondary outcomes (3)
Menstruation Symptom Scale
Menstrual Symptom Questionnaire (MSQ): The MSQ is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to rate the symptoms they experience related to menstruation between 1 (never) and 5 (always). The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, and the lowest score is 22. The MSQ score is calculated by taking the total score average of the items in the scale. An increase in the score average indicates an increase in the severity of menstrual symptoms.
Measured: three mounth
Functional and Emotional Dysmenorrhea Scale
This is a 14-item Likert-type scale used to measure dysmenorrhea functionally and emotionally. The options on the scale are: (1) It is not like my situation at all, (2) It is not like my situation at all, (3) It is both similar and not like my situation, (4) It is considered similar to my situation, (5) It is very similar to my situation. There are no reverse items in the scale items. The scale was developed to provide functional and emotional measurement of dysmenorrhea. As the scores obtained from the scale increase, the functional and emotional effects of dysmenorrhea also increase.
Measured: three mounth
Myotonometry (MyotonPRO)
Myotonometry is an objective measurement method for measuring the physiological properties of muscle tone, including stiffness. MyotonPRO is a small, non-invasive, handheld myotonometer that provides an objective measurement of the mechanical properties of muscles in vivo. This measurement is a non-invasive approach, where the response of the muscle is recorded using small mechanical stimuli given by the device. In our case, the measurement will be performed in the lower abdomen, at the level of the uterine fundus.
Measured: three mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start27 Jul 2023
- Primary completion1 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Model description
- 1. Structured myofascial release group 2. Tens (transcutaneous electrical nerve stimulation) group 3. group that includes lifestyle changes
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Sert, Medipol University
- Investigators
- SERT BUSE, Principal investigator, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744608
- Sponsor's protocol ID
- MEDIPOLU-FTR-BS-01
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Structured Myofascial Release in the Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06744608
- Acronym / sponsor ID
- MEDIPOLU-FTR-BS-01
- Conditions
- Primary Dysmenorrhea
- Keywords
- Myofascial Release, TENS (transcutaneous electrical nerve stimulation)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 20 Dec 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.
The aim of our research is to examine the effects of myofascial release techniques on symptoms in patients with primary dysmenorrhea. With this research, we aim to improve the clinical symptoms, pain and tension of primary dysmenorrhea with a structured manual therapy consisting of myofascial release and sacral mobilization in individuals with primary dysmenorrhea and an educational program that includes changes in daily life. Can Structured Myofascial Release Techniques Reduce Pain and Other Symptoms in Primary Dysmenorrhea? H0: Myofascial release techniques applied to individuals with primary dysmenorrhea have no effect on symptoms. H1: Myofascial release techniques applied to individuals with primary dysmenorrhea have an effect on symptoms.
Detailed description
Although primary dysmenorrhea is a common problem, especially among young women, there is generally no approach aimed at solving the main issue apart from symptomatic treatment or medication. Due to the side effects of medical treatments, many patients tend to opt for cheaper, non-medical, and non-aggressive methods.
The Weissman scale is scored between 0 and 3, where:
0: No dysmenorrhea
- Minimal (Able to work but feels discomfort)
- Moderate (Able to work but feels significant discomfort)
- Severe (Unable to work, bedridden) According to the Weissman scale, women in groups 1 and 2 continue with their daily lives or work/school but experience significant declines in their quality of life. On the other hand, individuals in group 3 suffer from work loss. Primary dysmenorrhea is associated with a significant economic burden caused by absenteeism and 2 to 3 times higher healthcare costs. Considering this cycle repeats in every menstrual period, a treatment approach is needed not only to alleviate symptoms but also to address the pathophysiological mechanisms of dysmenorrhea. The aim is to reduce elevated prostaglandin levels, decrease increased uterine contractions, relieve ischemia, and improve blood flow using structured myofascial release techniques.
Structured Myofascial Release Techniques
Myofascial release techniques involve manual physiotherapy administered by a physiotherapist to eliminate myofascial trigger points, reduce muscle tension, and alleviate associated pain. Structured myofascial release techniques aim to:
Provide relaxation in smooth muscles and ligaments through direct techniques to reduce increased uterine contractions.
Achieve neural relaxation via sacral mobilization. Incorporate a dual relaxation protocol involving both mechanical correction and stimulation of the parasympathetic nervous system.
It is thought that applying these two methods together increases the likelihood of treatment success. In 2022, a study demonstrated that myofascial release provided more effective relaxation and symptom reduction compared to pelvic floor exercises in patients with primary dysmenorrhea. This project aims to evaluate the effectiveness of myofascial release techniques and investigate whether the treatment effect persists after the intervention.
TENS (transcutaneous electrical nerve stimulation)
In the TENS group, pain is reduced by direct application to the lower abdominal area through the gate control theory. TENS is hypothesized to have two effects:
Elevating the threshold of pain signals caused by uterine hypoxia and hypercontractility by sending afferent impulses via the large-diameter sensory fibers of the same nerve root, thereby reducing the perception of painful uterine signals.
Stimulating endorphin release from peripheral nerves and the spinal cord Research Question and Hypotheses Research Question: Can structured myofascial release techniques reduce pain and other symptoms in the treatment of primary dysmenorrhea?
H0: Myofascial release techniques have no effect on the symptoms of individuals with primary dysmenorrhea.
H1: Myofascial release techniques have an effect on the symptoms of individuals with primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Structured myofascial release group 2. Tens (transcutaneous electrical nerve stimulation) group 3. group that includes lifestyle changes
| Arm | Type | Receives |
|---|---|---|
| Structured Myofascial Release | Active comparator | Other: Structured Myofascial ReleaseThe treatment program consisting of myofascial release techniques includes the following applications; 1. Anterolateral abdominal wall release (Until relaxation is felt); Along the fundus of the uterus, along the ovaries and the broad ligament of the uterus, combined mobilization with rotation of the uterus and hips in the supine position and sacral mobilization for three minutes. Myofascial release was started by placing the fingers/dorsal side of the hand on the fascia. Pressure was applied on the soft tissue. After the restricted layer was felt, the fascia was moved along the surface while in contact with the lower layers. The technique was applied for an average of 60-90 seconds, but if necessary, it was continued until relaxation was felt. |
| TENS (transcutaneous electrical nerve stimulation) | Active comparator | Device: tens (transcutaneous electrical nerve stimulation)The TENS (transcutaneous electrical nerve stimulation) treatment program was applied by a physiotherapist using two 50X50 mm electrodes on the lower abdomen using conventional TENS at 200 μs, 100 Hz, and 30 min. . |
| lifestyle changes | Active comparator | Behavioral: lifestyle changesWithin the scope of education including lifestyle changes; Good nutrition. (what to take and what to avoid), supplements, relaxation training, meditation, exercise recommendations, avoiding tobacco smoke, warm showers, quality sleep (at least 6-8 hours), wearing comfortable clothes are included in the recommendations. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primary dysmenorrhea diagnosed by a specialist gynecologist with 'Ultrasonography',
- Complaints of pain and spasm in the first 2 days of the menstrual cycle,
- Being two or above on the Weissmann scale,
- Being between the ages of 18-30,
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- Having pelvic pathology,
- Having a history of previous pregnancy,
- Using a medication that causes or affects dysmenorrhea,
- Being pregnant,
- Using intrauterine or oral contraceptives,
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 |
|---|---|---|
| Structured Myofascial Releasehaftada 2 seans 8 hafta boyunca toplam 16 seans uygulama yapıldı | Other | Structured Myofascial Release |
| tens (transcutaneous electrical nerve stimulation)A total of 16 sessions of application were applied to the groups, 2 sessions per week for 8 weeks. | Device | TENS (transcutaneous electrical nerve stimulation) |
| lifestyle changesA presentation including lifestyle changes was prepared and training was provided. | Behavioural | lifestyle changes |
Primary outcome
McGILL Pain Scale Short Form
Time frame: three mounth
The McGill pain questionnaire consists of four sections. In the first section, the individual marks the location of the pain on the body diagram and determines whether the pain comes from deep or superficial. In the second section, there are 20 word groups that examine pain in terms of sensory, perceptual and evaluative aspects. The individual is asked to select a set of words that fit their pain and mark the word that fits their pain within the selected set. The third section includes the relationship between pain and time. In the fourth section, five word groups ranging from "mild" pain to "unbearable" pain are defined to determine the severity of pain. The McGill Pain Questionnaire determines the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of pain that can be experienced by the individual. A high score indicates high level pain.
3 secondary outcomes
Menstruation Symptom Scale
Time frame: three mounth
Functional and Emotional Dysmenorrhea Scale
Time frame: three mounth
Myotonometry (MyotonPRO)
Time frame: three mounth
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 20 Dec 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. This study is not recruiting at the moment.
SERT BUSE principal investigator
İstanbul Medipol 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 Structured Myofascial Release, tens (transcutaneous electrical nerve stimulation) and lifestyle changes in people with Primary Dysmenorrhea, run by Medipol 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 5 inclusion and 6 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 20 Dec 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. 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?
McGILL Pain Scale Short Form (time frame: three mounth). 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 20 Dec 2024.