Effects of Far Infrared Radiation on Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

Effects of Far Infrared Radiation on Fibromyalgia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225519
• Other study ID #: FibroFIR
• Status: Completed
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: August 27, 2019

Study information

• Verified date: February 2022
• Source: Clinical Academic Center (2CA-Braga)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 27, 2019
• Est. primary completion date: July 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• long-sleeved white shirt impregnated with a long-infrared irradiation
Usage of an experimental shirt for a period of 12 weeks.
• long-sleeved white shirt
Usage of an experimental shirt for a period of 12 weeks.

Locations

Country	Name	City	State
Portugal	2CA-Braga	Braga

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Academic Center (2CA-Braga)

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	Tender Points	Number of tender points at the moment.	Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Secondary	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.