Effects of Far Infrared Radiation on Fibromyalgia Patients

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).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: long-sleeved white shirt impregnated with a long-infrared irradiation; Device: long-sleeved white shirt

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4710
    • 2CA-Braga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; Usage of a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic for a period of 12 weeks.	Device: long-sleeved white shirt impregnated with a long-infrared irradiation; Usage of an experimental shirt for a period of 12 weeks.
Placebo Comparator: Placebo arm; 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.	Device: long-sleeved white shirt; Usage of an experimental shirt for a period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WPI	The widespread pain index (WPI) is a 19-point checklist (score range: 0-19) that assesses the presence of pain or tenderness score means (within the prior seven days) in 19 specific areas of the body; each affected area receives one point.	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
SS	The symptom severity score (SS) quantifies symptom severity on a 0-12 scale by assessing problems with fatigue, cognitive dysfunction and unrefreshed sleep over the past week. These scores are summed for a measure of the physician's impression of the number of somatic symptoms the patient has on a 0-3 scale.	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIQR	Revised Fibromyalgia Impact Questionnaire (FIQR) is a 21-item self-administered questionnaire. All items are visual analogue scales with 11 boxes discreetly scoring from 0 to 10 with 10 being 'worst'. All questions are framed in the context of the past 7 days.	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Tender Points	Number of tender points at the moment.	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
EQ-5D	EQ-5D is a standardized measure of health-related quality of life. EQ-5D assesses health status in terms of five dimensions of health (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression).	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.

Collaborators and Investigators

• Sponsor: Clinical Academic Center (2CA-Braga)

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): July 18, 2019
• Study Completion (Actual): August 27, 2019

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: FibroFIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No