Effects of Abdominal Muscle Strengthening Using Stabilizer Pressure Biofeedback on Menstrual Symptoms and Abdominal Muscle Strength in Young Women With Primary Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- Menstrual Symptom Severity
研究概览
简要总结
This randomized controlled trial aims to investigate the effects of abdominal muscle strengthening exercises using a stabilizer pressure biofeedback device on menstrual symptoms and abdominal muscle strength in young women with primary dysmenorrhea. Primary dysmenorrhea, characterized by painful menstrual cramps without underlying pelvic pathology, is common among women of reproductive age and can negatively affect quality of life.
In this study, 58 female participants aged 18-25 with regular menstrual cycles and a Visual Analog Scale (VAS) pain score of ≥4 will be randomly assigned to either an intervention group or a control group. The intervention group will perform abdominal strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, three times per week for 6 weeks (excluding menstruation weeks).
The main outcomes include menstrual symptom severity (assessed by the Menstrual Symptom Scale), pain intensity (VAS), and abdominal muscle strength (measured using the stabilizer pressure biofeedback device). The results will help determine whether targeted abdominal muscle training can reduce menstrual symptoms and improve muscle strength in women with primary dysmenorrhea.
详细描述
Primary dysmenorrhea (PD) is one of the most common gynecological problems in women of reproductive age, characterized by spasmodic cramps in the lower abdomen before or during menstruation, without pelvic pathology. The underlying pathophysiology involves increased release of prostaglandin F2α during menstruation, leading to stronger uterine contractions, reduced blood flow, hypoxia, and pain. PD often begins soon after menarche and may be accompanied by nausea, vomiting, diarrhea, fatigue, and sleep disturbances.
Conventional treatment approaches include pharmacological methods such as nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives. However, these treatments may have side effects and limited patient compliance. Non-pharmacological interventions, especially exercise programs, have shown potential in reducing menstrual pain by increasing endorphin release, relaxing uterine muscles, and improving regional blood flow. Strengthening abdominal and core muscles can improve pelvic stability and potentially reduce dysmenorrhea symptoms.
The stabilizer pressure biofeedback unit is a simple, non-invasive device that provides visual feedback during muscle activation, helping to target deep stabilizing muscles such as the transversus abdominis. By enhancing activation capacity, it may improve abdominal muscle strength and reduce menstrual symptoms.
Study Design:
This is a randomized, controlled, single-blind trial. Fifty-eight eligible women aged 18-25 with regular menstrual cycles, a VAS score ≥4, and no diagnosis of secondary dysmenorrhea or other gynecological disorders will be enrolled. Participants will be allocated to the intervention or control group using permuted block randomization. Assessments will be conducted three times: at baseline (first day of the menstrual cycle), mid-intervention (week 3-4), and post-intervention (week 8).
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
- Single (Outcomes Assessor)
盲法说明
This study uses a single-blind design in which the outcomes assessor is unaware of participants' group allocation. Participants and care providers are aware of the assigned interventions, but the assessor responsible for data collection and outcome evaluation remains blinded throughout the trial to reduce measurement bias.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-25 years
- •Regular menstrual cycles
- •Diagnosed with primary dysmenorrhea (no secondary dysmenorrhea or other gynecological disorders)
- •Menstrual pain intensity ≥ 4 on the Visual Analog Scale (VAS) during the menstrual cycle
- •Willingness to participate and ability to provide informed consent
排除标准
- •Diagnosis of secondary dysmenorrhea or other gynecological disorders (e.g., endometriosis, adenomyosis, uterine fibroids)
- •Current pregnancy or breastfeeding
- •History of abdominal or pelvic surgery in the past 6 months
- •Current use of hormonal therapy or analgesic medication that could affect menstrual pain assessment
- •Participation in regular abdominal or core strengthening exercise programs within the last 3 months
- •Any musculoskeletal, neurological, or systemic condition that could interfere with exercise performance or study participation
研究组 & 干预措施
Intervention - Abdominal Muscle Strengthening with Stabilizer Pressure Biofeedback
Participants perform a structured exercise program targeting lumbar and abdominal muscles, guided by a stabilizer pressure biofeedback device. Sessions are supervised three times per week for 6 weeks (excluding menstruation weeks) and include mobility, stretching, and strengthening exercises to improve abdominal muscle activation and core stability.
干预措施: Abdominal Muscle Strengthening Exercises with Stabilizer Pressure Biofeedback (Behavioral)
Control - No Abdominal Muscle Strengthening Intervention
Participants receive no abdominal muscle strengthening program during the study period. They continue their usual daily activities without any supervised exercise intervention.
结局指标
主要结局
Menstrual Symptom Severity
时间窗: Change from Baseline (Week 0) to Post-intervention (Week 8)
Change in menstrual symptom severity as assessed by the Menstrual Symptom Scale (MSS). The MSS consists of 22 items scored on a 5-point Likert scale, with higher scores indicating more severe symptoms.
Pain Intensity
时间窗: Change from Baseline (Week 0) to Post-intervention (Week 8)
Visual Analog Scale 0-10 cm (0 = no pain, 10 = worst pain). Outcome is mean change from baseline to Week 8.
Abdominal Muscle Activation/Strength (Pressure Biofeedback)
时间窗: Change from Baseline (Week 0) to Post-intervention (Week 8)
Abdominal muscle activation measured with a Stabilizer Pressure Biofeedback Unit (mmHg). Lower pressure during correct drawing-in reflects better transversus abdominis activation. Outcome is change from baseline to Week 8
次要结局
未报告次要终点
研究者
Sanem ŞENER
Assistant Professor, PhD
Bulent Ecevit University