Fibromyalgia SyndromeNCT00447083
Benefits of Tanning in Fibromyalgia Patients
A study testing UVB and Non-UVB in people with Fibromyalgia Syndrome, run by Wake Forest University at 1 site in United States.
Trial summary
To establish whether ultraviolet light exposure acutely reduces perceptions of pain in patients with fibromyalgia. To establish whether a series of UV light exposures has a cumulative effect on fibromyalgia pain. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- UVB and Non-UVB
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fibromyalgia patients who meet the fibromyalgia criteria, and who have been diagnosed with fibromyalgia by a board certified rheumatologist. The fibromyalgia criteria {as defined by the American College of Rheumatology (ACR)} require the patient to have: at least 3 months of widespread pain defined as: bilateral; above and below the waist, including axial skeletal pain; and pain to palpation with 4kg of pressure at a minimum of 11 out of 18 predefined tender points.
- Ideally, patients should not be taking medication for treatment of fibromyalgia, and they should not be taking psychoactive medications on an as needed basis for treatment of fibromyalgia. However, if patients are taking psychoactive or other medications for the treatment of fibromyalgia, then they should be on a stable dose, defined as no change in dosage in the 4 weeks prior to study enrollment.
- Patients must agree to not partake in tanning bed UV exposure during the study.
Who cannot join
- Fitzpatrick skin type 1 ("never tan, always burn")
- Past or present skin cancer
- Current use of photosensitizing drugs (current use of photosensitizing drugs will be evaluated via a patient questionnaire at time of patient enrollment - see Appendix 1),, psychoactive medications (not a stable dose, defined as no change in dosage in the 4 weeks prior to study enrollment), or illicit drugs
- Pregnant, planning to become pregnant, or breast feeding
- Significant visual discrimination of UV versus non-UV conditions
- Greater than 6 indoor tanning sessions over the past year
- Concurrent photosensitive disease, positive antinuclear antibody test, positive anti-Smith antibody test, or positive anti-dsDNA test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study of the Effect of Ultraviolet Light on Pain in Persons With Fibromyalgia Syndrome
- To establish whether ultraviolet light exposure acutely reduces perceptions of pain in patients with fibromyalgia.
- To establish whether a series of UV light exposures has a cumulative effect on fibromyalgia pain.
Read the detailed description
Fibromyalgia is a common chronic disorder characterized by widespread pain and fatigue. It occurs primarily in women, especially women of childbearing age. The effectiveness of treatment for this disorder is limited, and alternative medical treatments are commonly used.
Ultraviolet (UV) light exposure gives a sense of relaxation. It is unknown whether UV exposure has any effect on pain, particularly in patients with fibromyalgia. Through studies performed with RO3 funding from the National Institute of Drug Abuse (NIDA), we demonstrated that in frequent tanners, appearance is less important than UV-induced relaxation in motivating tanning behavior. Moreover, we determined that UV light has reinforcing properties apart from any psychosocial benefits of having a tan. One subject in our study reported low back pain relief from the UV exposure condition.
This is a two-year proposal that is the beginning of a long-term plan to assess whether indoor tanning ultraviolet light exposure has a therapeutic effect for patients with chronic pain. To this end, we will determine the effect of UV light on fibromyalgia pain in a controlled, double blind clinical trial of UV exposure. This approach is carefully designed to separate the effects of UV exposure on pain from potential confounds associated with the tanning procedure, including any perceived benefits of having a tan. The results of this study will increase our understanding of the specific influence of UV light on persistence in tanning behavior.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- UVB, Non-UVB
- Keywords
- Tanning, Musculoskeletal, Fibromyalgia Syndrome
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVBDevice
Also called Ultraviolet Light
UVB exposure by a tanning bed
Non-UVBProcedure or surgery
Non-UVB exposure by a tanning bed
| Study group | Role | What they receive |
|---|---|---|
| UVB First | Experimental | Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with UV. The dose of UV (time of exposure) will be progressively increased from 3 minutes to 9 minutes over the 6 visits to acclimate subjects to UV light. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive UVB tanning bed treatment first, then switch to the non-UVB treatment. Receives: Device: UVB; Procedure: Non-UVB |
| Non-UVB First | Placebo comparator | Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with non-UV bulbs. The time of exposure will be progressively increased from 3 minutes to 9 minutes over the 6 visits to mirror UVB treatment. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive non-UVB tanning bed treatment first, then switch to the UVB treatment. Receives: Device: UVB; Procedure: Non-UVB |
| UVB | Experimental | The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of UVB. Receives: Device: UVB |
| Non-UVB | Placebo comparator | The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of non-UVB exposure Receives: Procedure: Non-UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief Success Rates (Phase I)
Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.
Measured: 2 weeks
Pain Score- Likert Scale(Phase II)
Pain will be assessed on an 11-point pain scale where 0=no pain and 10=worst possible pain. A 30% improvement in reported pain will be considered a treatment "success.
Measured: 6 weeks
Secondary outcomes (2)
Post-treatment Pain Scores- Likert Scale (Phase I)
As a secondary outcome, the post-treatment pain scores between the UV and non-UV exposures given on the first day the dose is given will be compared. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain
Measured: 2 weeks
Pain Scores of the UV and Non-UV Exposure (Phase II)
The pain scores were assessed using a Likert Scale. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain.
Measured: 4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startMay 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fibromyalgia SyndromeStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R. Feldman, M.D., Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447083
- Sponsor's protocol ID
- II-CDR-Fibromyalgia
- Status last verified
- Oct 2018
- First submitted
- 13 Mar 2007
- Last updated
- 13 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Ultraviolet Light on Pain in Persons With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT00447083
- Acronym / sponsor ID
- II-CDR-Fibromyalgia
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Tanning, Musculoskeletal, Fibromyalgia Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Mar 2007 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To establish whether ultraviolet light exposure acutely reduces perceptions of pain in patients with fibromyalgia.
- To establish whether a series of UV light exposures has a cumulative effect on fibromyalgia pain.
Detailed description
Fibromyalgia is a common chronic disorder characterized by widespread pain and fatigue. It occurs primarily in women, especially women of childbearing age. The effectiveness of treatment for this disorder is limited, and alternative medical treatments are commonly used.
Ultraviolet (UV) light exposure gives a sense of relaxation. It is unknown whether UV exposure has any effect on pain, particularly in patients with fibromyalgia. Through studies performed with RO3 funding from the National Institute of Drug Abuse (NIDA), we demonstrated that in frequent tanners, appearance is less important than UV-induced relaxation in motivating tanning behavior. Moreover, we determined that UV light has reinforcing properties apart from any psychosocial benefits of having a tan. One subject in our study reported low back pain relief from the UV exposure condition.
This is a two-year proposal that is the beginning of a long-term plan to assess whether indoor tanning ultraviolet light exposure has a therapeutic effect for patients with chronic pain. To this end, we will determine the effect of UV light on fibromyalgia pain in a controlled, double blind clinical trial of UV exposure. This approach is carefully designed to separate the effects of UV exposure on pain from potential confounds associated with the tanning procedure, including any perceived benefits of having a tan. The results of this study will increase our understanding of the specific influence of UV light on persistence in tanning behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| UVB First | Experimental | Device: UVB, Procedure: Non-UVBSubjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with UV. The dose of UV (time of exposure) will be progressively increased from 3 minutes to 9 minutes over the 6 visits to acclimate subjects to UV light. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive UVB tanning bed treatment first, then switch to the non-UVB treatment. |
| Non-UVB First | Placebo comparator | Device: UVB, Procedure: Non-UVBSubjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with non-UV bulbs. The time of exposure will be progressively increased from 3 minutes to 9 minutes over the 6 visits to mirror UVB treatment. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive non-UVB tanning bed treatment first, then switch to the UVB treatment. |
| UVB | Experimental | Device: UVBThe subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of UVB. |
| Non-UVB | Placebo comparator | Procedure: Non-UVBThe subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of non-UVB exposure |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fibromyalgia patients who meet the fibromyalgia criteria, and who have been diagnosed with fibromyalgia by a board certified rheumatologist. The fibromyalgia criteria {as defined by the American College of Rheumatology (ACR)} require the patient to have: at least 3 months of widespread pain defined as: bilateral; above and below the waist, including axial skeletal pain; and pain to palpation with 4kg of pressure at a minimum of 11 out of 18 predefined tender points.
- Ideally, patients should not be taking medication for treatment of fibromyalgia, and they should not be taking psychoactive medications on an as needed basis for treatment of fibromyalgia. However, if patients are taking psychoactive or other medications for the treatment of fibromyalgia, then they should be on a stable dose, defined as no change in dosage in the 4 weeks prior to study enrollment.
- Patients must agree to not partake in tanning bed UV exposure during the study.
Key exclusion criteria (7 listed)
- Fitzpatrick skin type 1 ("never tan, always burn")
- Past or present skin cancer
- Current use of photosensitizing drugs (current use of photosensitizing drugs will be evaluated via a patient questionnaire at time of patient enrollment - see Appendix 1),, psychoactive medications (not a stable dose, defined as no change in dosage in the 4 weeks prior to study enrollment), or illicit drugs
- Pregnant, planning to become pregnant, or breast feeding
- Significant visual discrimination of UV versus non-UV conditions
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 |
|---|---|---|
| UVBAlso: Ultraviolet LightUVB exposure by a tanning bed | Device | Non-UVB First, UVB, UVB First |
| Non-UVBNon-UVB exposure by a tanning bed | Procedure or surgery | Non-UVB, Non-UVB First, UVB First |
Primary outcome
Pain Relief Success Rates (Phase I)
Time frame: 2 weeks
Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.
Pain Score- Likert Scale(Phase II)
Time frame: 6 weeks
Pain will be assessed on an 11-point pain scale where 0=no pain and 10=worst possible pain. A 30% improvement in reported pain will be considered a treatment "success.
2 secondary outcomes
Post-treatment Pain Scores- Likert Scale (Phase I)
Time frame: 2 weeks
Pain Scores of the UV and Non-UV Exposure (Phase II)
Time frame: 4 weeks post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Steven R. Feldman, M.D., Ph.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UVB and Non-UVB in people with Fibromyalgia Syndrome, run by Wake Forest University at 1 site in United States.
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 7 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 13 Nov 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Relief Success Rates (Phase I) (time frame: 2 weeks). 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 13 Nov 2018.