NCT06379269

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 18, 2024

Last Update Submit

April 23, 2024

Conditions

Keywords

myofascial pain syndromesmartphone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • functional questionnaire

    20 minutes

Study Arms (2)

App group

EXPERIMENTAL
Device: App healthcare

Control group

ACTIVE COMPARATOR
Other: Control

Interventions

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

App group
ControlOTHER

general education and home rehab program

Control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For those diagnosed with myofascial pain syndrome by a rehabilitation physician, the diagnostic conditions meet the five major signs, including:
  • Regional pain,
  • Transfer pain,
  • Muscle tight band,
  • Tender points in the tight band. ,
  • Limitation of joint mobility,
  • And symptoms consistent with any of the items, including:
  • Complaints of pain that appear after applying pressure on tender points,
  • Local throbbing reaction,
  • Pain disappears after injection or after stretching

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

May 1, 2024

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04