Effects of Far Infrared Radiation on Fibromyalgia Patients

Clinical Academic Center (2CA-Braga)

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: long-sleeved white shirt impregnated with a long-infrared irradiation; Device: long-sleeved white shirt

Study type: Interventional

Funder types: Other

Identifiers

NCT05225519

FibroFIR

Details and patient eligibility

About

This study aimed to evaluate the effectiveness of infrared radiation in improving the various symptoms of fibromyalgia syndrome, by using a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic, as well as the adherence to it and its applicability in daily routines.

A prospective, experimental, randomized, and double-blind study was carried. The study was implemented over 7 months, with a total of 5 visits for each patient. Participants were randomly allocated in experimental or control group. Those included in the experimental group received a shirt impregnated with ceramic emitting long infrared waves while participants in the placebo group received an exactly looking shirt, but not impregnated with ceramic emitting long infrared waves. Each visit comprised clinical evaluation and self-report scales filling (WPS, SS and FIQR scales).

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age superior to 18 years-old
• ability to freely sign the informed consent form
• generalized pain index scores (WPI ≥ 7 and SS score ≥ 5, or WPI ≥ 3 and ≤ 6 with SS ≥ 9, presence of abdominal pain and / or with depression and / or headache, in the last 6 months, at the screening consultation).

Exclusion criteria

• dermatological diseases
• Other rheumatic and /or autoimmune diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Experimental arm

Experimental group

Description:

Usage of a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic for a period of 12 weeks.

Treatment:

Device: long-sleeved white shirt impregnated with a long-infrared irradiation

Placebo arm

Placebo Comparator group

Description:

Usage of a long-sleeve white shirt (similar to the one in the experimental arm) but with no long-infrared technology for a period of 12 weeks.

Treatment:

Device: long-sleeved white shirt