Benefits of Tanning in Fibromyalgia Patients
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Purpose
- 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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia Syndrome |
Procedure: Ultraviolet Light |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of the Effect of Ultraviolet Light on Pain in Persons With Fibromyalgia Syndrome |
- A 30% improvement in reported pain will be considered a treatment "success." As a secondary outcome, we will compare post-treatment pain scores between the UV and non-UV exposures given on the first day the dose is given (A vs. B in table 4).
- A treatment "success" in Phase 2 will be defined as a 30% reduction in pain relative to the baseline reported at screening on the 11-point pain scale.
- Detailed pain assessment
- Mood
- Quality of life
- Tanning blind
| Enrollment: | 19 |
| Study Start Date: | May 2005 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Steven R. Feldman, M.D., Ph.D. | Wake Forest University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00447083 History of Changes |
| Other Study ID Numbers: | II-CDR-Fibromyalgia |
| Study First Received: | March 13, 2007 |
| Last Updated: | February 12, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
Tanning Musculoskeletal Fibromyalgia Syndrome |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013