Effects of Far Infrared Radiation on Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: long-sleeved white shirt impregnated with a long-infrared irradiation; Device: long-sleeved white shirt

• Registration Number: NCT05225519
• Lead Sponsor: Clinical Academic Center (2CA-Braga)

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-26
• Primary Completion: 2019-07-18
• Study Completion: 2019-08-27
• Study First Submitted: 2022-01-25
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-01
• Last Update Submitted: 2022-02-01
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	long-sleeved white shirt impregnated with a long-infrared irradiation	Usage of a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic for a period of 12 weeks.
Placebo arm	long-sleeved white shirt	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.

Primary Outcome Measures

Name	Time	Method
SS	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.	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.
WPI	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.	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.

Secondary Outcome Measures

Name	Time	Method
Tender Points	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.	Number of tender points at the moment.
FIQR	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.	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.
EQ-5D	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.	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).

Trial Locations

Locations (1)

2CA-Braga; 🇵🇹 Braga, Portugal