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CompletedNCT05904990Updated Mar 19, 2024

High-intensity Laser Therapy Improves Pain, Health Status and Quality of Life in Women With Fibromyalgia

An interventional study of traditional exercise therapy only and HILT alongside traditional exercise therapy in Fibromyalgia, sponsored by October 6 University. Completed at 1 site in Egypt. Open to female participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-03-19.

Sponsored by October 6 University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2023, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
Female
01

Study summary

This study will be conducted to investigate High-intensity laser therapy improves pain, health status and quality of life in women with fibromyalgia

02

Conditions studied

03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 52 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
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

Exclusion Criteria:

  • uncontrolled diabetes
  • known history of cancer
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    traditional exercise therapy only

    This 50-minute program included a 10-minute warm-up phase (treadmill walking at a comfortable speed), 30 minutes of stretching exercises for (glutei, paraspinal muscles, hamstring, pectoralis, scalenus, intercostal muscles, and trapezius), and a 10-minute cool-down involving self-stretching and respiratory exercises.

    Device: traditional exercise therapy only

  • Experimental
    HILT alongside traditional exercise therapy,

    pulsed Nd: YAG laser device (HIRO 3.0; ASA Laser, Arcugnano, Italy). This equipment delivers pulsed laser light at a wavelength of 1,064 nm, with a very high peak power of 3 kW and energy density ranging from 360 to 1,780 mJ/cm2.

    Device: traditional exercise therapy only · Device: HILT alongside traditional exercise therapy

Interventions

  • Devicetraditional exercise therapy only

    50-minute program included a 10-minute warm-up phase (treadmill walking at a comfortable speed), 30 minutes of stretching exercises for (glutei, paraspinal muscles, hamstring, pectoralis, scalenus, intercostal muscles, and trapezius), and a 10-minute cool-down involving self-stretching and respiratory exercises

  • DeviceHILT alongside traditional exercise therapy

    YAG laser device (HIRO 3.0; ASA Laser, Arcugnano, Italy). This equipment delivers pulsed laser light at a wavelength of 1,064 nm, with a very high peak power of 3 kW and energy density ranging from 360 to 1,780 mJ/cm2. It operates with short pulse durations between 120 and 150 μs, at low frequencies of 10 to 40 Hz, and has a duty cycle of about 0.1%.

06

What researchers measure

Primary outcomes

  1. Revised Fibromyalgia Impact Questionnaire (FIQR)

    assesses the overall severity of FM and health status based on participant ratings. It encompasses three key domains similar to the FIQ (function, overall impact, and symptoms), with additional inquiries regarding memory, tenderness, balance, and environmental sensitivity

    Time frame: up to 6 weeks

  2. Visual Analog Scale (VAS)

    10 cm, where patients rated their pain on a scale from 0 ("no pain") to 10 ("extremely severe pain ") over the past 3 days

    Time frame: up to 6 weeks

  3. pressure algometer

    This tool comprises a circular rubber tip (1 cm2) and a pressure gauge for displaying readings in kilograms. Given the rubber tip's 1 cm² area, measurements were reported in kilograms per square centimeter (kg/cm2). The algometer has a measurement range from 0 to 10 kg, with increments of 0.1 kg. The instrument was pressed against the skin's surface at a right angle, and the force exerted was registered on a manometer.

    Time frame: up to 6 weeks

07

Study locations

1 site
  • Kerolous Ishak Shehata Kelini
    Giza, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05904990
Lead sponsor
October 6 University
Responsible party
Kerolous Ishak Shehata (principle investigator, October 6 University) — Principal investigator
First posted
Jun 15, 2023
Start date
Jan 29, 2023
Primary completion
Jun 1, 2023
Completion
Sep 1, 2023
Last update
Mar 19, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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