Benefits of Tanning in Fibromyalgia Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00447083|
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : February 16, 2009
- 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 or disease||Intervention/treatment||Phase|
|Fibromyalgia Syndrome||Procedure: Ultraviolet Light||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Effect of Ultraviolet Light on Pain in Persons With Fibromyalgia Syndrome|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
- 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
- Quality of life
- Tanning blind
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447083
|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 Health Sciences|