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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: traditional exercise therapy only; Device: HILT alongside traditional exercise therapy

• Registration Number: NCT05904990
• Lead Sponsor: October 6 University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-01-29
• Primary Completion: 2023-06-01
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Study Completion: 2023-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
traditional exercise therapy only	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.
HILT alongside traditional exercise therapy,	traditional exercise therapy only	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.
HILT alongside traditional exercise therapy,	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	up to 6 weeks	10 cm, where patients rated their pain on a scale from 0 ("no pain") to 10 ("extremely severe pain ") over the past 3 days
Revised Fibromyalgia Impact Questionnaire (FIQR)	up to 6 weeks	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
pressure algometer	up to 6 weeks	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.

Trial Locations

Locations (1)

Kerolous Ishak Shehata Kelini; 🇪🇬 Giza, Egypt