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

NCT ID: NCT05904990

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-29

Study Completion Date

2023-09-01

Brief Summary

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

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

High intensity laser
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

traditional exercise therapy only

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

HILT alongside traditional exercise therapy

Intervention Type DEVICE

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%.

traditional exercise therapy only

Intervention Type DEVICE

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

Interventions

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HILT 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%.

Intervention Type DEVICE

traditional 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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October 6 University

OTHER

Sponsor Role lead

Responsible Party

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Kerolous Ishak Shehata

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kerolous Ishak Shehata Kelini

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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p.t.REC\012\004507

Identifier Type: -

Identifier Source: org_study_id

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