Investigating the Effects of Right/Left Discrimination Training on Pain Perception and Functional Disability in Fibromyalgia Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Functional disability by The Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
To determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.
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)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia according to the 2016 American College of Rheumatology criteria
- •Adults between 35 - 55 years old
- •Both sexes
- •Stable medication use for at least one month prior to enrollment
排除标准
- •History of other musculoskeletal or neurological disorders
- •Current involvement in another pain management program or study
研究组 & 干预措施
Intervention group
Right/left discrimination training: The training program will consist of tasks such as identifying the laterality of images (e.g., hands, feet, faces) and sounds (e.g., spatially localized sounds). The tasks will be designed with increasing levels of difficulty to challenge participants and promote skill development.
Training schedule: Participants will be instructed to engage in the right/left discrimination training for 20 minutes per day, 5 days per week, over a six-week period. They will be encouraged to complete the training sessions at consistent times to support habit formation.
Monitoring and feedback: The research team will remotely monitor participants' progress and provide personalized feedback on a weekly basis. This will include reviewing performance metrics within the app, discussing any challenges or barriers to adherence, and offering guidance to support continued engagement in the training program.
干预措施: Right/left discrimination training (Other)
Control group
Usual care: Participants will continue their usual care management for fibromyalgia, including any prescribed medications and physician consultations. No specific right/left discrimination training will be provided to the control group.
干预措施: usual care (Other)
结局指标
主要结局
Functional disability by The Fibromyalgia Impact Questionnaire (FIQ)
时间窗: Changes in FIQ at baseline, 6 weeks and 12 weeks.
The Fibromyalgia Impact Questionnaire (FIQ) will be used to assess functional disability at baseline, 6 weeks, and 12 weeks. The FIQ is a self-report questionnaire containing 21 items related to physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being.
Pain intensity by The Numeric Pain Rating Scale (NPRS)
时间窗: Changes in pain intensity at baseline, 6 weeks and 12 weeks.
The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity at baseline, 3 weeks, 6 weeks (post-intervention), and 12 weeks (follow-up). Participants will rate their pain on an 11-point scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
Right/left discrimination ability by Recognize smartphone application
时间窗: Changes in Right/left discrimination ability at baseline, 6 weeks and 12 weeks.
Recognize app by NOI will be used to assess right/left discrimination ability at baseline, 6 weeks, and 12 weeks. This test will include a series of right/left discrimination tasks similar to those used in the training program.
次要结局
- Cognitive function by The Montreal Cognitive Assessment (MoCA)(Changes in MoCA at baseline, 6 weeks and 12 weeks.)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University