Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory
研究概览
简要总结
The aim of this study was to investigate the effects of Therapeutic Neuroscience Education (TNE) in individuals with Fibromyalgia (FM). The study included 25 females with FM, randomly separated into two groups as the intervention group (Clinical Pilates Exercises+TNE, n=11) and the control group (Clinical Pilates Exercises, n=14).
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
- None
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
- •age between 18-65 years,
- •female gender,
- •a VAS of at least 40mm to report the pain intensity of the last week,
- •having been diagnosed with FM for at least 1 year to present a range of somatic and cognitive symptoms in addition to widespread pain,
- •using a fixed dose of medication for at least the past 6 months (serotonin noradrenaline reuptake inhibitors [Ex, duloxetine, milnacipran]; alpha 2-delta receptor ligand [Ex, pregabalin]; gabapentinoids).
排除标准
- •the presence of another disease which may affect the physical condition,
- •cognitive impairment at a level preventing cooperation,
- •being pregnant,
- •inability to understand or speak Turkish,
- •concurrent autoimmune or inflammatory disease,
- •the presence of a central nervous system disease (eg multiple sclerosis, Parkinson's disease),
- •serious psychiatric conditions (eg, psychotic disorders) that would prevent participation,
- •participation in a rehabilitation program in the past year,
- •have been exercising regularly for 6 months,
- •not participating in at least 75% of treatments.
结局指标
主要结局
Brief Pain Inventory
时间窗: 7 min
This is a short and easy-to-apply inventory that can be used to assess pain, which consists of the two sections of Pain Severity (4 items) and Pain Interference (7 items). The total score in both categories ranges from 0 to 10, with higher scores indicating more pain and more pain causes more disability.
Tampa Scale for Kinesiophobia
时间窗: 10 min
The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.
Widespread Pain Index
时间窗: 10 min
The WPI evaluates the patient's pain in the last week in terms of 19 regions and is scored between 0-19.
Symptom Severity Scale
时间窗: 7 min
The SSS is scored between 0-12.
Fibromyalgia Impact Questionnare
时间窗: 10 min
Total score ranging from 0 to 100. Higher scores indicate worse functional status
Visual Analogue Scale
时间窗: 5 min
VAS is used to convert values that cannot be measured numerically, such as pain, into numerical values. Two end definitions of the parameter to be evaluated are written at the two ends of a 10 cm line and the patient is asked to mark this line indicating the appropriate level of their condition. In this study, 0='no pain' and 10='worst possible pain' were defined.
Pain Catastrophizing Scale
时间窗: 10 min
The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.
次要结局
- Dynamic Loewenstein Occupational Therapy Cognitive Assessment(1 hour)
- Biopsychosocial Questionnaire(10 min)
研究者
Elif Gur Kabul
research assistant
Pamukkale University