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

October 6 University52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia

Interventions

traditional exercise therapy onlyDEVICE

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 therapyDEVICE

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%.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Kerolous Ishak Shehata Kelini

Giza, Egypt

Outcomes

Primary Outcomes

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

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

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

Data from ClinicalTrials.gov

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