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临床试验/NCT04970511
NCT04970511已完成不适用

Comparison of the Effects of Face-to-Face and Internet-Based Basic Body Awareness Therapy in Fibromyalgia Syndrome

University of Beykent1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2021年7月1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
41
试验地点
1
主要终点
The Revised Fibromyalgia Impact Questionnaire (FIQR)

研究概览

简要总结

The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.

H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.

H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.

详细描述

The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.

H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.

H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.

Goals:

  1. Investigation of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome.
  2. Comparison of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • To be between the ages of 18-65
  • Being diagnosed with FMS according to ACR 2016 criteria
  • To be diagnosed with FMS at least 6 months before the study
  • Reported pain intensity > 4 (Visual Analog Scale 0-10),
  • Individuals that do not have barriers to basic body awareness therapy.

排除标准

  • Pregnancy or intention to become pregnant within the study period.
  • Substance and alcohol abuse, major psychiatric disorder (preventing compliance), uncontrolled hypertension, diabetes, congestive heart failure, or other serious chronic medical condition that puts the patient at risk for the clinician to expose the patient to potentially serious consequences of their illness
  • Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy
  • Those who have suffered from any musculoskeletal, neurological, rheumatological disorder or any condition that may interfere with evaluations (advanced respiratory or orthopedic problems such as fractures, sprains or strains, or spinal surgery) in the past 12 months -

结局指标

主要结局

The Revised Fibromyalgia Impact Questionnaire (FIQR)

时间窗: 8 weeks

Limitations and functional disability in patients with fibromyalgia will be evaluated.

次要结局

  • Algometer(8 weeks)
  • Posture Screen Mobile (PSM)(8 weeks)
  • The short-form McGill Pain Questionnaire(8 weeks)
  • Trunk repositioning error(8 weeks)
  • Awareness-Body-Chart=ABC(8 weeks)
  • Postural stability(8 weeks)
  • Single Leg Balance(8 weeks)
  • Pittsburgh Sleep Quality Index(8 weeks)
  • SF-36 (the MOS 36-item short-form health survey)(8 weeks)
  • Plasma Fibrinogen and Haptoglobin Protein Levels(8 weeks)

研究者

发起方
University of Beykent
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özge Tahran

MSc.,Physiotherapist, Lecturer

University of Beykent

研究点 (1)

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