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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Device: App healthcare; Other: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Lan Chiu, Doc; Phone Number: 6737 +8866-6-2353535; Email: yalanchiu@gs.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Control; general education and home rehab program
Experimental: App group	Device: App healthcare; Self-developed app: includes home stretching and strengthening exercises, muscle release technique instruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
current pain visual analogue scale	pain will be evaluated with visual analogue scale(VAS). 0 means no pain at all;10 means extremely painful.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional questionnaire	corresponding functional questionnaire to the specific body part of the subject. For the neck area, the Neck Disability Index is used. The higher the score, the more disability the patient is. For the lower back area, the Oswestry Disability Index is used. The higher the score, the more disability the patient is. For the upper limb, the Disability of the Arm, Shoulder, and Hand is used. The higher the score, the more severe the patient is. For the lower limb, the Lower Extremity Functional Scale is used. The higher the score, the more sever the patient is.	20 minutes

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: National Cheng Kung University; National Science and Technology Council

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: smartphone; myofascial pain syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: CMUH112-REC3-160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No