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Completed

NCT Number: NCT05904990

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

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kerolous Ishak Shehata Kelini

Giza, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • WPI ≥ 7/19 pain sites and SSS ≥ 5/12 or WPI between > 3-6/19 and SSS > 9/12
  • symptoms have been present at a similar level for at least 3 months
  • the patient does not have another disorder that would otherwise sufficiently explain the pain
  • generalized pain, defined as pain in at least four of five regions, is present

Exclusion criteria

  • uncontrolled diabetes
  • known history of cancer

Treatment and study plan

traditional exercise therapy only

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

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%.

Primary outcomes

  1. Revised Fibromyalgia Impact Questionnaire (FIQR)

    Time frame: 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

  2. Visual Analog Scale (VAS)

    Time frame: 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

  3. pressure algometer

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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