Fibromyalgia
Conditions
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
Interventions
DEVICEtraditional 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
DEVICEHILT 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%.
Sponsors
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
High intensity laser
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
Egypt
Outcome results
None listed