NCT05915585

Brief Summary

Eosinophilic fasciitis (EF) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. Conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. This case report will describe use of high-intensity laser therapy (HILT) using the Mectronic Exand MY high-intensity laser system in a patient with EF, highlighting its potential as an alternative or adjunct treatment option.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

June 18, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

June 14, 2023

Last Update Submit

June 14, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain intensity via Numeric pain rating scale

    Changes in pain intensity at baseline and 4 weeks

  • Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)

    Changes in DASH at baseline and 4 weeks

  • Quality of life via Short Form-36 Health Survey

    Changes in Short Form-36 Health Survey at baseline and 4 weeks

  • Adverse event

    adverse events are recorded by the patient and therapist

    4 Weeks

Study Arms (1)

High-Intensity Laser Therapy (HILT)

EXPERIMENTAL
Device: High-Intensity Laser Therapy

Interventions

The patient will receive HILT using the Mectronic Exand MY high-intensity laser system with the following parameters: Wavelength: 1064 nm (near-infrared) Power: 12 W Energy density: 8 J/cm² Pulse duration: 200 µs Treatment duration: 10 minutes Frequency: 3 sessions per week for 4 weeks Total energy delivered: 96 J per treatment session

High-Intensity Laser Therapy (HILT)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Eosinophilic fasciitis.

You may not qualify if:

  • a diagnosis unrelated to Eosinophilic fasciitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Eosinophilic Fasciitis

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single participant case study
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 18, 2023

Primary Completion

July 19, 2023

Study Completion

July 20, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations