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Effect of High Intensity Laser for Treatment Females With Fibromyalgia: Single Blinded Placebo-randomized Controlled

Sponsor
October 6 University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05904990
Collaborator
(none)
60
Enrollment
2
Arms
4.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study will be conducted to investigate the effect of high intensity laser for treatment females with fibromyalgia

Condition or Disease Intervention/Treatment Phase
  • Device: High Intensity Laser
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
High intensity laserHigh intensity laser
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of High Intensity Laser for Treatment Females With Fibromyalgia: Single Blinded Placebo-randomized Controlled
Anticipated Study Start Date :
Jun 12, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: The laser probe - with the small spacer (3.1cm2) - was applied perpendicularly on the skin.

Device: High Intensity Laser
High Intensity Laser
Experimental: Sham High intensity laser (HIL) on trigger points without output

Device: High Intensity Laser
High Intensity Laser

Outcome Measures

Primary Outcome Measures

  1. pain intensity [up to 4 weeks]

    Numeric rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. WPI ≥ 7/19 pain sites and SSS ≥ 5/12 or WPI between > 3-6/19 and SSS > 9/12

  2. symptoms have been present at a similar level for at least 3 months

  3. the patient does not have another disorder that would otherwise sufficiently explain the pain

  4. generalized pain, defined as pain in at least four of five regions, is present

Exclusion Criteria:

  • uncontrolled diabetes

  • known history of cancer

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kerolous Ishak Shehata, principle investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05904990
Other Study ID Numbers:
  • p.t.REC\012\004507
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes

Study Results

No Results Posted as of Jun 15, 2023