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Completed

NCT Number: NCT05225519

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).

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

2CA-Braga

Braga, 4710, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

long-sleeved white shirt

Device

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

Primary outcomes

  1. WPI

    Time frame: 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.

  2. SS

    Time frame: 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.

Secondary outcomes

  1. FIQR

    Time frame: 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.

  2. Tender Points

    Time frame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.

    Number of tender points at the moment.

  3. EQ-5D

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Clinical Academic Center (2CA-Braga)

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2022
Registry last updated
Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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