FibromyalgiaNCT05225519
Effects of Far Infrared Radiation on Fibromyalgia Patients
A study testing long-sleeved white shirt impregnated with a long-infrared irradiation and long-sleeved white shirt in people with Fibromyalgia, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- long-sleeved white shirt impregnated with a long-infrared irradiation and long-sleeved white shirt
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 sitePortugal
- Study dates
- 26 Mar 2018to 27 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- dermatological diseases
- Other rheumatic and /or autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Fibromyalgia
- Being tested
- long-sleeved white shirt impregnated with a long-infrared irradiation, long-sleeved white shirt
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-sleeved white shirt impregnated with a long-infrared irradiationDevice
Usage of an experimental shirt for a period of 12 weeks.
long-sleeved white shirtDevice
Usage of an experimental shirt for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Usage of a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic for a period of 12 weeks. Receives: Device: long-sleeved white shirt impregnated with a long-infrared irradiation |
| Placebo arm | Placebo comparator | 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. Receives: Device: long-sleeved white shirt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
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.
Measured: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Secondary outcomes (3)
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.
Measured: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Tender Points
Number of tender points at the moment.
Measured: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
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).
Measured: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start26 Mar 2018
- Primary completion18 Jul 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Academic Center (2CA-Braga)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225519
- Sponsor's protocol ID
- FibroFIR
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Far Infrared Radiation on Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT05225519
- Acronym / sponsor ID
- FibroFIR
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Clinical Academic Center (2CA-Braga)University, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 18 Jul 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: long-sleeved white shirt impregnated with a long-infrared irradiationUsage of a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic for a period of 12 weeks. |
| Placebo arm | Placebo comparator | Device: long-sleeved white shirtUsage 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- dermatological diseases
- Other rheumatic and /or autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long-sleeved white shirt impregnated with a long-infrared irradiationUsage of an experimental shirt for a period of 12 weeks. | Device | Experimental arm |
| long-sleeved white shirtUsage of an experimental shirt for a period of 12 weeks. | Device | Placebo arm |
Primary outcome
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.
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.
3 secondary outcomes
FIQR
Time frame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Tender Points
Time frame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
EQ-5D
Time frame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long-sleeved white shirt impregnated with a long-infrared irradiation and long-sleeved white shirt in people with Fibromyalgia, run by Clinical Academic Center (2CA-Braga) at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WPI (time frame: Change between baseline and after 4, 8 and 12 weeks of wearing the shirt.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.