Effects of Far Infrared Radiation on Fibromyalgia Patients
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
long-sleeved white shirt impregnated with a long-infrared irradiation
long-sleeved white shirt
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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
Sites / Locations
- 2CA-Braga
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental arm
Placebo arm
Arm Description
Usage of a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic for a period of 12 weeks.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Tender Points
Number of tender points at the moment.
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).
Full Information
NCT ID
NCT05225519
First Posted
January 25, 2022
Last Updated
February 1, 2022
Sponsor
Clinical Academic Center (2CA-Braga)
1. Study Identification
Unique Protocol Identification Number
NCT05225519
Brief Title
Effects of Far Infrared Radiation on Fibromyalgia Patients
Official Title
Effects of Far Infrared Radiation on Fibromyalgia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
July 18, 2019 (Actual)
Study Completion Date
August 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Academic Center (2CA-Braga)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Usage of a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic for a period of 12 weeks.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
long-sleeved white shirt impregnated with a long-infrared irradiation
Intervention Description
Usage of an experimental shirt for a period of 12 weeks.
Intervention Type
Device
Intervention Name(s)
long-sleeved white shirt
Intervention Description
Usage of an experimental shirt for a period of 12 weeks.
Primary Outcome Measure Information:
Title
WPI
Description
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.
Time Frame
Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Title
SS
Description
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.
Time Frame
Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Secondary Outcome Measure Information:
Title
FIQR
Description
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.
Time Frame
Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Title
Tender Points
Description
Number of tender points at the moment.
Time Frame
Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Title
EQ-5D
Description
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).
Time Frame
Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
2CA-Braga
City
Braga
ZIP/Postal Code
4710
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Far Infrared Radiation on Fibromyalgia Patients
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