- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05915585
High-Intensity Laser Therapy for Eosinophilic Fasciitis
June 14, 2023 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University
Efficacy of High-Intensity Laser Therapy for the Management of Eosinophilic Fasciitis: A Case Report
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed M ElMeligie, Ph.d
- Phone Number: +201064442032
- Email: mohamed.elmeligie@acu.edu.eg
Study Locations
-
-
Giza
-
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
- Recruiting
- Outpatient clinic of faculty of physical therapy, Ahram Canadian University
-
Contact:
- Mohamed M ElMeligie, Ph.d
- Phone Number: 01064442032
- Email: mohamed.elmeligie@acu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients diagnosed with Eosinophilic fasciitis.
Exclusion Criteria:
- a diagnosis unrelated to Eosinophilic fasciitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Intensity Laser Therapy (HILT)
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity via Numeric pain rating scale
Time Frame: Changes in pain intensity at baseline and 4 weeks
|
Changes in pain intensity at baseline and 4 weeks
|
|
|
Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Time Frame: Changes in DASH at baseline and 4 weeks
|
Changes in DASH at baseline and 4 weeks
|
|
|
Quality of life via Short Form-36 Health Survey
Time Frame: Changes in Short Form-36 Health Survey at baseline and 4 weeks
|
Changes in Short Form-36 Health Survey at baseline and 4 weeks
|
|
|
Adverse event
Time Frame: 4 Weeks
|
adverse events are recorded by the patient and therapist
|
4 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 18, 2023
Primary Completion (Estimated)
July 19, 2023
Study Completion (Estimated)
July 20, 2023
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Actual)
June 23, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010/012023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eosinophilic Fasciitis
-
Meyer Children's Hospital IRCCSRecruitingEosinophilic FasciitisUnited States, United Kingdom, Croatia, Italy, Romania, Sweden, Germany, Israel, Slovenia, Spain, Turkey (Türkiye)
-
Radboud University Medical CenterCompleted
-
University Hospital, GhentCompletedDebilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)Belgium
-
Charite University, Berlin, GermanyCompletedScleroderma, Systemic | Morphea | Graft Vs Host Disease | Eosinophilic Fasciitis | Skin SclerosisGermany
-
Joint & Vascular InstituteRecruitingPlantar Fasciitis | Plantar Fasciitis, ChronicUnited States
-
Beni-Suef UniversityRecruitingPlanter FasciitisEgypt
-
Cairo UniversityRecruiting
-
Sivas State HospitalRecruitingPlantar FasciitisTurkey (Türkiye)
-
Mahidol UniversityNot yet recruiting
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