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

October 6 University

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: traditional exercise therapy only; Device: HILT alongside traditional exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05904990

p.t.REC\012\004507

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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52 participants in 2 patient groups

traditional exercise therapy only

Experimental group

Description:

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.

Treatment:

Device: traditional exercise therapy only

HILT alongside traditional exercise therapy,

Experimental group

Description:

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.

Treatment:

Device: HILT alongside traditional exercise therapy

Device: traditional exercise therapy only