Effectiveness Verification of a Smartphone-based System for Assessment and Health Care on Myofascial Pain Syndrome

NCT ID: NCT06379269

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-12-31

Brief Summary

Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle.With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention.

Detailed Description

Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle. Common treatments include medications, dry needles, and physical therapy. Among them, physical therapy aims to treat the involved muscle. With the advancement of technology, mHealth (mobile health) has been gradually developed in recent years. With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention.Methods: Feasibility evaluation: Subjects with MPS will be recruited to perform the assessment of the system on their own. And the assessment results for the system will be compared with clinical assessment results done by a rehabilitation physician. The feasibility of the smartphone app will be analyzed through the system usability scale.Health care effects evaluation: Subjects with MPS will be recruited and randomly assigned to the intervention group and control group. The intervention group will receive the smartphone app health care program, and the control group will receive health education. Outcomes will be measured before and after the intervention. The training effects of the app will be evaluated by comparing it with the control group.Expected Results & Contribution: The smartphone app for identifying the muscle presenting TrPs on MPS subjects is feasible. The healthcare effects of the smartphone app for MPS subjects are effective. Offering an easy-used and effective tool for clinicians and subjects with MPS to evaluate and improve pain and symptoms.

Conditions

Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

App group

Group Type: EXPERIMENTAL

App healthcare

Intervention Type: DEVICE

Self-developed app: includes home stretching and strengthening exercises, muscle release technique instruction.

Control group

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

general education and home rehab program

Interventions

App healthcare

Self-developed app: includes home stretching and strengthening exercises, muscle release technique instruction.

Intervention Type: DEVICE

Control

general education and home rehab program

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For those diagnosed with myofascial pain syndrome by a rehabilitation physician, the diagnostic conditions meet the five major signs, including:

1. Regional pain,

2. Transfer pain,

3. Muscle tight band,

4. Tender points in the tight band. ,

5. Limitation of joint mobility,

• And symptoms consistent with any of the items, including:

1. Complaints of pain that appear after applying pressure on tender points,

2. Local throbbing reaction,

3. Pain disappears after injection or after stretching

Exclusion Criteria

• Have any neurological diseases that may cause pain,
• have a history of surgery in the past six months,
• the affected area is in a state of acute inflammation,
• have open wounds, etc.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: collaborator

National Science and Technology Council

FED

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li-Wei Chou

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ya-Lan Chiu, Doc

Role: CONTACT

yalanchiu@gs.ncku.edu.tw

+8866-6-2353535 ext. 6737

Other Identifiers

CMUH112-REC3-160

Identifier Type: -

Identifier Source: org_study_id