Back to resultsHigh-Intensity Laser Therapy for Eosinophilic Fasciitis
Primary Purpose
Eosinophilic Fasciitis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High-Intensity Laser Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Fasciitis
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with Eosinophilic fasciitis. Exclusion Criteria: a diagnosis unrelated to Eosinophilic fasciitis
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High-Intensity Laser Therapy (HILT)
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity via Numeric pain rating scale
Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Quality of life via Short Form-36 Health Survey
Adverse event
adverse events are recorded by the patient and therapist
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05915585
Brief Title
High-Intensity Laser Therapy for Eosinophilic Fasciitis
Official Title
Efficacy of High-Intensity Laser Therapy for the Management of Eosinophilic Fasciitis: A Case Report
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2023 (Anticipated)
Primary Completion Date
July 19, 2023 (Anticipated)
Study Completion Date
July 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Fasciitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single participant case study
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-Intensity Laser Therapy (HILT)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
High-Intensity Laser Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity via Numeric pain rating scale
Time Frame
Changes in pain intensity at baseline and 4 weeks
Title
Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Time Frame
Changes in DASH at baseline and 4 weeks
Title
Quality of life via Short Form-36 Health Survey
Time Frame
Changes in Short Form-36 Health Survey at baseline and 4 weeks
Title
Adverse event
Description
adverse events are recorded by the patient and therapist
Time Frame
4 Weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with Eosinophilic fasciitis.
Exclusion Criteria:
a diagnosis unrelated to Eosinophilic fasciitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-Intensity Laser Therapy for Eosinophilic Fasciitis
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