Right/Left Discrimination Training on Fibromyalgia Patients

Study Overview
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Brief Summary
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To determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.

Official Title
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Investigating the Effects of Right/Left Discrimination Training on Pain Perception and Functional Disability in Fibromyalgia Patients: A Randomized Controlled Trial

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Right/left discrimination training
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: History of other musculoskeletal or neurological disorders Current involvement in another pain management program or study

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Other: Right/left discrimination training<br>* Participants will use recognize app by Neuro-orthopedic institute (NOI) for daily right/left discrimination training. The training will include visual and auditory stimuli, with tasks such as identifying the laterality of images and sounds. Participants will engage in training for 20 minutes per day, 5 days per week, over a six-week period. Weekly monitoring and feedback will be provided by the research team<br>|
| Active Comparator: Control group<br>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. | Other: usual care<br>* 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. Follow-up assessments: Participants in the control group will undergo the same follow-up assessments as the intervention group to evaluate changes in pain perception, functional disability, and cognitive function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity by The Numeric Pain Rating Scale (NPRS) | 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). | Changes in pain intensity at baseline, 6 weeks and 12 weeks. | 
| Functional disability by The Fibromyalgia Impact Questionnaire (FIQ) | 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. | Changes in FIQ at baseline, 6 weeks and 12 weeks. | 
| Right/left discrimination ability by Recognize smartphone application | 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. | Changes in Right/left discrimination ability at baseline, 6 weeks and 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function by The Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function at baseline, 6 weeks, and 12 weeks. The MoCA is a brief screening tool designed to detect mild cognitive impairment and includes tasks related to memory, language, visuospatial skills, attention, and executive function. | Changes in MoCA at baseline, 6 weeks and 12 weeks. |