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临床试验/NCT06038214
NCT06038214已完成不适用

The Effect of Core Exercises on Pelvic Dysfunction, Sexual Dysfunction, Pain, Sleep Quality and Quality of Life in Women With Fibromyalgia

Inonu University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Female Sexual Dysfunction Scale

研究概览

简要总结

In fibromyalgia patients, exercise is needed to reduce symptoms and to prevent muscle weakness with fatigue and pain. Core exercise retrains and strengthens deep postural spinal muscles such as the multifidus and transverse abdominis by promoting neuromuscular control, maintaining the dynamic stability of the spine and thus reducing pain. By performing core exercises, the pelvic floor, which forms the lower base of the core, is strengthened.

Objective: It was planned to investigate the effects of core exercises on pelvic floor dysfunction, sexual dysfunction, pain, sleep quality and quality of life in women with fibromyalgia.

Materials and Methods: It was designed as randomized control. Sexually active women with fibromyalgia syndrome between the ages of 18-65 will be included in the study. After the patients are selected from the relevant stage with the improbable random sampling method, the patients who accept to participate in the study and meet the inclusion criteria will be assigned to one of the groups in which the core exercise or home program is applied. Evaluations will be evaluated for each group before starting the exercise program and 1 day after the last session, following the completion of 2 sessions per week for 8 weeks. Pain Visual Analog Scale; fibromyalgia impact level Revised Fibromyalgia Impact Questionnaire (FIQR); pelvic floor dysfunction Pelvic Floor Impact Questionnaire (PFIQ); sexual dysfunction Female Sexual Function Scale; sleep quality: Pittsburgh Sleep Quality Index; short quality of life It is planned to be evaluated with Form-36(SF-36). Conclusion: The effects of core exercises on pelvic floor dysfunction, sexual dysfunction, pain, sleep quality and quality of life will be evaluated and interpreted by comparing the evaluations before and after treatment and between groups.

详细描述

Fibromyalgia (FM) is a non-articular, chronic rheumatic disease of unknown etiology, characterized by widespread musculoskeletal pain, sleep disturbance, mood changes, fatigue, and the presence of multiple tender points. Diagnostic criteria were defined by the American Rheumatism Association (ARA) in 1990. To diagnose FM, there should be widespread pain and tenderness at 11 or more of 18 specific points (1).

Although the etiopathogenesis of FM is still unknown, triggering factors such as physical trauma, surgical intervention, infections, acute or chronic emotional stress may play a role (2). Various findings such as muscular symptoms accompanying chronic pain, cognitive complaints, depression, insomnia and fatigue have been described in patients with FM (2). chronic pain seen in FM; It creates physical and emotional stress such as sleep, fatigue and cognitive symptoms. In addition, unwillingness to move or fear of movement may develop in individuals due to chronic pain (2).

Various psychopathological disorders have been reported in FM. It is estimated that 1/3 of his patients have minor depression or anxiety and anxiety state disorder. However, it is unknown whether anxiety and depression in FM cause chronic pain or contribute to the severity of symptoms (1). Despite various complaints of patients with fibromyalgia, the absence of a significant disorder in physical examination and laboratory tests suggests that the symptoms may be of psychological origin (2). Since the etiology of fibromyalgia syndrome is unknown, pharmacological and non-pharmacological treatment methods should be used in patient-specific combinations according to the prominent symptoms and their severity (2).

Sexuality is an important part of life and is associated with the well-being of the individual. Sexuality covers many issues, starting with the self-image of the person and the relationship with his partner (3). Sexual dysfunction is defined as the satisfaction of not participating in sexual acts (3). The development of sexual dysfunction in women with fibromyalgia is thought to be associated with many factors such as symptoms, pain, anxiety, depression, and drug therapy (3).

Few studies have been done on the sexuality of women with fibromyalgia (4), and studies have found a relationship between fibromyalgia and sexual dysfunction (4) In addition, considering that women with fibromyalgia have an increase in pain, fatigue, and decrease in muscle strength (5), Fusco et al. concluded that women with fibromyalgia exhibited weaker pelvic floor muscles and also more frequent lower urinary tract symptoms compared to the healthy control group (5). For this reason, a relationship between pelvic floor involvement and impaired sexual function in women with fibromyalgia is considered (5).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Female Sexual Dysfunction Scale

时间窗: 8 weeks

Sexual Dysfunction: Will be measured by the Female Sexual Dysfunction Scale. The scale consists of 19 questions. Each question has six options that need to be answered, and each item is scored from zero to five. In the structure of the scale; There are six sub-dimensions: desire, arousal, lubrication, orgasm, satisfaction, and pain. The person scores between 4 and 95 on the scale. Permission has been obtained to use the survey.

Visual Analog Scale (VAS)

时间窗: 8 weeks

Pain: Regional neck and back pain during rest and activity will be evaluated with the help of Visual Analog Scale (VAS). The VAS is a 10cm scale that evaluates 0 points as "no pain" and 10 points as "the worst pain imaginable".

Pittsburgh Sleep Quality Index

时间窗: 8 weeks

Sleep Quality: Will be measured by the Pittsburgh Sleep Quality Index. Identification of good and bad sleep and assessment of sleep quality. It consists of a total of 24 questions, 19 of which are self-assessment and 5 of which are answered by the person's spouse or roommate. The questions are collected in 7 sub-scales. These; subjective sleep quality, sleep delay, sleep duration, habitual sleep activity, sleep disturbance, sleep medication use and daytime dysfunction. Each subscale is scored between 0-3 points. The total score is from 0-21. Questions asked to an individual's spouse or roommate are not included in the calculation. Permission has been obtained to use the survey

Pelvic Floor Impact Questionnaire (PFIQ )

时间窗: 8 weeks

Pelvic floor assessment: Pelvic Floor Impact Questionnaire (PFIQ) Pelvic Floor Impact Questionnaire) will be used for measurement. PFIQ is a pelvic floor quality of life questionnaire used to assess the effects of bowel, bladder, and/or pelvic symptoms on an individual's activities of daily living, social relationships, and emotions.

Short Form-36 (SF-36)

时间窗: 8 weeks

Quality of life: Short Form-36 (SF-36) scale will be used. Evaluation of the quality of life of SF-36 developed for this purpose. Validity and reliability studies were conducted in Turkey. SF-36 is used to compare general and specific populations, demonstrate the health benefits of different treatments, and monitor patients. In the evaluation of KF-36, which consists of a total of 36 items, the last 4 weeks are taken into account. Due to the release of the SF-36 v2.0, the use of v1.0 does not require permission.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naciye Dilruba Tektas Gulbil

msc physiotherapist

Inonu University

研究点 (1)

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