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临床试验/NCT04509934
NCT04509934已完成不适用

The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea: Long-Term Follow-Up

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Visual Analogue Scale

研究概览

简要总结

The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms.

详细描述

The purpose of this study was to reveal the effects of CTM on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms. The participants included to this study were randomised into two groups with simple randomisation method. CTM was performed to participants in both groups included the basic region (Sacral and lumbar), lower thoracic (between T12-T7) and anterior pelvic regions. In Group 1, starting at the end of the menstrual cycle, CTM was applied for 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period. Participants in the Group 2 CTM was started with the completion of menstrual cycle, 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks). Both short and long strokes were used during manipulation. Each stroke was repeated for three times first on the right and then on the left side of all manipulated regions. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The treatment was started from the basic region and proceeded to other regions according to the vascular reaction of the connective tissue. Each session lasted 5 to 20 minutes, depending on the size of the treated region. During manipulation, the pad of the middle finger was in contact with the patient's skin. The finger was placed on the skin at 45° angle with distal interphalangeal joint in flexion and moved to cause traction. During back treatment, the participant was asked to sit erect, with hips, knees, and ankles at 90° flexion and thighs and feet are fully supported. During the treatment of anterior pelvic region, the patient was in a supine position with pillows placed under the head and knees. Treatment was performed by a trained physiotherapist. The participants' intensity of pain, fatigue and sleep quality were assessed with Visual Analogue Scale. Depressive symptoms and anxiety status, general health and premenstrual symptoms were assessed with Beck Depression Inventory, Beck Anxiety Inventory, General Health Questionnaire and Premenstrual Syndrome Scale, respectively. All measurements were repeated 5 times; baseline, after the first menstruation following the intervention period, 3th, 6th and 12th months after treatment.

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

The statistical analyses will be performed by the statistics specialist that does not know anything about the methodology of the study.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being in a age range 18-30
  • Diagnosed with Primary Dysmenorrhea by a gynecologist
  • Having a regular menstrual cycle (28±7 days)
  • Being nulliparous
  • Having menstrual pain intensity above 5cm according to Visual Analog Scale

排除标准

  • Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes
  • Having a positive pregnancy test
  • History of pelvic surgery
  • Usage of oral contraceptives or antidepressants for at least 3 months
  • Having irregular menstrual cycles (defined as lasting<21or>35 days)
  • Having a history or an ultrasonographic observation of pathological conditions indicating secondary dysmenorrhea

结局指标

主要结局

Visual Analogue Scale

时间窗: 12th month after treatment

Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."

次要结局

  • General Health Questionnaire(12th month after treatment)
  • Beck Depression Inventory(12th month after treatment)
  • Beck Anxiety Inventory(12th month after treatment)
  • Premenstrual Syndrome Scale(12th month after treatment)
  • Visual Analogue Scale(12th month after treatment)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aybike Senel

Research Assistant, Sub-investigator, Physiotherapist, MSc

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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