N/A
N=19
Benefits of Tanning in Fibromyalgia Patients
Fibromyalgia Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00447083 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Pain Relief Success Rates (Phase I) — 33; 16 percentage of exposures with relief
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UVB (Device); Non-UVB (Procedure)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- Wake Forest University
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Relief Success Rates (Phase I) |
33; 16 | — |
| PRIMARY Pain Score- Likert Scale(Phase II) |
4.55; 4.95 | — |
| SECONDARY Post-treatment Pain Scores- Likert Scale (Phase I) |
4.89; 5.21 | — |
| SECONDARY Pain Scores of the UV and Non-UV Exposure (Phase II) |
4.65; 5.54 | .1811 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00447083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.