Right/Left Discrimination Training on Fibromyalgia Patients

NCT05915598 | Unknown

• 1 other identifier: 012/0059000012
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Cognitive function by The Montreal Cognitive Assessment (MoCA)

  Changes in MoCA at baseline, 6 weeks and 12 weeks.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Right/left discrimination training OTHER

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 group

usual care OTHER

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.

Control group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• History of other musculoskeletal or neurological disorders
• Current involvement in another pain management program or study

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: June 25, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 4, 2024
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)