Back to resultsRight/Left Discrimination Training on Fibromyalgia Patients
Primary Purpose
Fibromyalgia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Right/left discrimination training
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05915598
Brief Title
Right/Left Discrimination Training on Fibromyalgia Patients
Official Title
Investigating the Effects of Right/Left Discrimination Training on Pain Perception and Functional Disability in Fibromyalgia Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 4, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine whether a targeted right/left discrimination training program can improve pain perception and functional disability in fibromyalgia patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Right/left discrimination training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity by The Numeric Pain Rating Scale (NPRS)
Description
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).
Time Frame
Changes in pain intensity at baseline, 6 weeks and 12 weeks.
Title
Functional disability by The Fibromyalgia Impact Questionnaire (FIQ)
Description
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.
Time Frame
Changes in FIQ at baseline, 6 weeks and 12 weeks.
Title
Right/left discrimination ability by Recognize smartphone application
Description
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.
Time Frame
Changes in Right/left discrimination ability at baseline, 6 weeks and 12 weeks.
Secondary Outcome Measure Information:
Title
Cognitive function by The Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Changes in MoCA at baseline, 6 weeks and 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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Right/Left Discrimination Training on Fibromyalgia Patients
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