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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904990
• Other study ID #: p.t.REC\012\004507
• Status: Completed
• Phase: N/A
• Start date: January 29, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2024
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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
• 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%.

Locations

Country	Name	City	State
Egypt	Kerolous Ishak Shehata Kelini	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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