Effects of Far Infrared Radiation on Fibromyalgia Patients

NCT ID: NCT05225519

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2019-08-27

Brief Summary

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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

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental arm

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Usage of an experimental shirt for a period of 12 weeks.

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.

Group Type PLACEBO_COMPARATOR

long-sleeved white shirt

Intervention Type DEVICE

Usage of an experimental shirt for a period of 12 weeks.

Interventions

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

Usage of an experimental shirt for a period of 12 weeks.

Intervention Type DEVICE

long-sleeved white shirt

Usage of an experimental shirt for a period of 12 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinical Academic Center (2CA-Braga)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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2CA-Braga

Braga, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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FibroFIR

Identifier Type: -

Identifier Source: org_study_id

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