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

High-intensity Laser Therapy Improves Pain, Health Status and Quality of Life in Women With Fibromyalgia: A Single Blinded-randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: traditional exercise therapy only; Device: HILT alongside traditional exercise therapy

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Kerolous ishak shehata kelini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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: 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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	up to 6 weeks

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: p.t.REC\012\004507

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No