Back to resultsEffect of High Intensity Laser for Treatment Females With Fibromyalgia: Single Blinded Placebo-randomized Controlled
Primary Purpose
Fibromyalgia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Laser
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria: WPI ≥ 7/19 pain sites and SSS ≥ 5/12 or WPI between > 3-6/19 and SSS > 9/12 symptoms have been present at a similar level for at least 3 months the patient does not have another disorder that would otherwise sufficiently explain the pain generalized pain, defined as pain in at least four of five regions, is present Exclusion Criteria: uncontrolled diabetes known history of cancer
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
The laser probe - with the small spacer (3.1cm2) - was applied perpendicularly on the skin.
Sham High intensity laser (HIL) on trigger points without output
Arm Description
Outcomes
Primary Outcome Measures
pain intensity
Numeric rating scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05904990
Brief Title
Effect of High Intensity Laser for Treatment Females With Fibromyalgia: Single Blinded Placebo-randomized Controlled
Official Title
Effect of High Intensity Laser for Treatment Females With Fibromyalgia: Single Blinded Placebo-randomized Controlled
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 29, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will be conducted to investigate the effect of high intensity laser for treatment females with fibromyalgia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
High intensity laser
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The laser probe - with the small spacer (3.1cm2) - was applied perpendicularly on the skin.
Arm Type
Experimental
Arm Title
Sham High intensity laser (HIL) on trigger points without output
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
High Intensity Laser
Intervention Description
High Intensity Laser
Primary Outcome Measure Information:
Title
pain intensity
Description
Numeric rating scale
Time Frame
up to 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
WPI ≥ 7/19 pain sites and SSS ≥ 5/12 or WPI between > 3-6/19 and SSS > 9/12
symptoms have been present at a similar level for at least 3 months
the patient does not have another disorder that would otherwise sufficiently explain the pain
generalized pain, defined as pain in at least four of five regions, is present
Exclusion Criteria:
uncontrolled diabetes
known history of cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerolous Kelini, Lecturer
Phone
+201229712126
Email
Kerolous.ishak.pt@o6u.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Effect of High Intensity Laser for Treatment Females With Fibromyalgia: Single Blinded Placebo-randomized Controlled
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