Benefits of Tanning in Fibromyalgia Patients

This study has been completed.
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00447083
First received: March 13, 2007
Last updated: February 12, 2009
Last verified: February 2009
  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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447083

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Steven R. Feldman, M.D., Ph.D. Wake Forest School of Medicine
  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 School of Medicine:
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 July 28, 2014