NCT Number: NCT06492148
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.
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Not applicable
Ankara, 06530, Turkey (Türkiye)
Location status: Recruiting
Beyza Yazgan Dagli
CONTACT
Beyza Yazgan Dagli
PRINCIPAL_INVESTIGATOR
Sevim B Olmez
PRINCIPAL_INVESTIGATOR
Zeynep B Alkan
PRINCIPAL_INVESTIGATOR
Zeynep Hazar Kanık
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Baseline (First menstruation cycle)
Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
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.
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.
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.
Time frame: Baseline (First menstruation cycle)
Menstrual Attitude Scale will be used to evaluate symptoms related to menstruation. High scores indicate a high awareness of menstruation.
Time frame: through study completion, an average of 3 months
Menstrual Attitude Scale will be used to evaluate symptoms related to menstruation. High scores indicate a high awareness of menstruation.
Time frame: Baseline (First menstruation cycle)
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.
Time frame: through study completion, an average of 3 months
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.
Time frame: Baseline (First menstruation cycle)
State and Trait Anxiety Scale is a self-assessment inventory that evaluates anxiety and consists of 40 items.
Time frame: through study completion, an average of 3 months
State and Trait Anxiety Scale is a self-assessment inventory that evaluates anxiety and consists of 40 items.
Time frame: Baseline (First menstruation cycle)
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).
Time frame: through study completion, an average of 3 months
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).
Contact information is provided by the study sponsor or research team.
Gazi University
Other
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
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