Right/Left Discrimination Training on Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915598
• Other study ID #: 012/0059000012
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2023
• Est. completion date: August 4, 2024

Study information

• Verified date: June 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 4, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Right/left discrimination training
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
• usual care
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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.