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

NCT05904990 | Completed

• 1 other identifier: p.t.REC\012\004507
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

traditional exercise therapy only

EXPERIMENTAL

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

HILT alongside traditional exercise therapy,

EXPERIMENTAL

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; Device: HILT alongside traditional exercise therapy

Interventions

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,; traditional exercise therapy only

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%.

HILT alongside traditional exercise therapy,

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• uncontrolled diabetes
• known history of cancer

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Kerolous Ishak Shehata Kelini

Giza, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: High intensity laser

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: January 29, 2023
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

EG (1)