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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Central Sensitization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Myofascial Release Group
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.
干预措施: Myofascial Release (Other)
Sham- Myofascial Release Group
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.
干预措施: Sham-Myofascial Release (Other)
结局指标
主要结局
Central Sensitization
时间窗: through study completion, an average of 3 months
Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
Pain Pressure Threshold
时间窗: 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.
Menstrual pain intensity
时间窗: 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.
Pain Pressure Threshold
时间窗: 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.
Central Sensitization
时间窗: Baseline (First menstruation cycle)
Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
Menstrual pain intensity
时间窗: 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.
次要结局
- The Body Awareness(through study completion, an average of 3 months)
- Menstrual Attitude(through study completion, an average of 3 months)
- Anxiety(through study completion, an average of 3 months)
- Health-related quality of life(through study completion, an average of 3 months)
- Menstrual Attitude(Baseline (First menstruation cycle))
- Health-related quality of life(Baseline (First menstruation cycle))
- Anxiety(Baseline (First menstruation cycle))
- The Body Awareness(Baseline (First menstruation cycle))
研究者
BEYZA YAZGAN DAĞLI
Research Assistant
Gazi University