Clinical trial NCT00447083: Benefits of Tanning in Fibromyalgia Patients
Official title: A Pilot Study of the Effect of Ultraviolet Light on Pain in Persons With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: Tanning
Musculoskeletal
Fibromyalgia Syndrome
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2007-03-14
Enrollment: 19
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Pain Relief Success Rates (Phase I)
timeFrame: 2 weeks
measure: Pain Score- Likert Scale(Phase II)
timeFrame: 6 weeks
Secondary outcomes:
measure: Post-treatment Pain Scores- Likert Scale (Phase I)
timeFrame: 2 weeks
measure: Pain Scores of the UV and Non-UV Exposure (Phase II)
timeFrame: 4 weeks post-treatment
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R. Feldman, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: