Comparison of Vibration Therapy, Classical Abdominal Massage, and Myofascial Release Applications in Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score
研究概览
简要总结
This randomized, assessor-blinded, four-arm, parallel-group controlled trial aims to compare the effects of vibration therapy, abdominal massage, and myofascial release with an education-only control intervention in women with primary dysmenorrhea. Seventy-two women aged 18 to 30 years will be randomized in a 1:1:1:1 ratio. All participants will receive standard education about primary dysmenorrhea. The three intervention groups will additionally receive their assigned treatment twice weekly for 12 weeks, covering three menstrual cycles. Menstrual pain, pain characteristics, pressure pain threshold, menstrual symptoms, and symptoms associated with central sensitization will be evaluated at baseline and after the intervention by a blinded assessor.
详细描述
Primary dysmenorrhea is a common condition characterized by menstrual pain that may negatively affect daily activities and school or work performance. This study will investigate three non-pharmacological treatment approaches for managing primary dysmenorrhea.
A total of 72 women aged 18 to 30 years with primary dysmenorrhea will be randomly assigned in a 1:1:1:1 ratio to one of four groups: vibration therapy, abdominal massage, myofascial release, or education-only control. All participants will receive standardized education about primary dysmenorrhea and menstrual pain management.
The vibration therapy group will receive treatment using a vibrating massage ball applied to the abdominal and lumbosacral regions. The abdominal massage group will receive standardized massage applied to the lower abdominal and suprapubic regions. The myofascial release group will receive treatment targeting the abdominal, lumbopelvic, and sacral regions. The control group will receive education only. The interventions will be administered twice weekly for 12 weeks, covering three menstrual cycles.
Assessments will be conducted at baseline and after the 12-week intervention. Outcomes will include menstrual pain characteristics, pressure pain threshold measured by algometry at six standardized anatomical points, menstrual symptoms, and symptoms associated with central sensitization. Outcome assessments will be performed by an assessor blinded to group allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Female participants aged 18 to 30 years.
- •Having regular menstrual cycles during the previous 6 months.
- •Having a diagnosis consistent with primary dysmenorrhea following evaluation by an obstetrician and gynecologist.
- •Experiencing menstrual pain in at least 2 of the previous 3 menstrual cycles.
- •Having menstrual pain intensity of 4 or higher on a 0-10 Visual Analog Scale.
- •Voluntarily agreeing to participate in the study and providing written informed consent.
排除标准
- •Secondary dysmenorrhea.
- •Diagnosis of endometriosis, uterine fibroids, ovarian cysts, or pelvic inflammatory disease.
- •History of gynecological surgery.
- •Pregnancy or suspected pregnancy.
- •Having given birth within the previous 6 months.
- •Recent initiation of hormonal treatment.
- •Chronic pelvic pain or a neurological, rheumatological, or systemic inflammatory disease.
- •Having received manual therapy or physiotherapy targeting the abdominal or lumbopelvic region within the previous 3 months.
- •Skin lesions, infection, open wounds, or other dermatological conditions in the treatment regions.
- •Any clinical condition considered a contraindication to vibration therapy.
- •Inability to comply with the study protocol -
结局指标
主要结局
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score
时间窗: Baseline and post-intervention at Week 12
The SF-MPQ consists of 15 pain descriptors, including 11 sensory and 4 affective items. Each item is rated from 0 (none) to 3 (severe). Item scores are summed to obtain a total score ranging from 0 to 45. Higher scores indicate greater pain severity. The change in total score from baseline to Week 12 will be compared among the study groups.
次要结局
- Change in Short-Form McGill Pain Questionnaire Sensory Subscore(Baseline and post-intervention at Week 12)
- Change in Short-Form McGill Pain Questionnaire Affective Subscore(Baseline and post-intervention at Week 12)
- Change in Pressure Pain Threshold Measured by Algometry(Baseline and post-intervention at Week 12)
- Change in Menstrual Symptom Questionnaire Mean Total Score(Baseline and post-intervention at Week 12)
- Change in Central Sensitization Inventory Total Score(Baseline and post-intervention at Week 12)
研究者
gizem boztas
Assistant professor
Istanbul Medipol University Hospital