Benefits of Tanning in Fibromyalgia Patients

Fibromyalgia Syndrome Clinical Trial

Official title:

A Pilot Study of the Effect of Ultraviolet Light on Pain in Persons With Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447083
• Other study ID #: II-CDR-Fibromyalgia
• Status: Completed
• Phase: N/A
• Start date: May 2005
• Est. completion date: September 2008

Study information

• Verified date: October 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Device:
• UVB
UVB exposure by a tanning bed

Procedure:
• Non-UVB
Non-UVB exposure by a tanning bed

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief Success Rates (Phase I)	Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.	2 weeks
Primary	Pain Score- Likert Scale(Phase II)	Pain will be assessed on an 11-point pain scale where 0=no pain and 10=worst possible pain. A 30% improvement in reported pain will be considered a treatment "success.	6 weeks
Secondary	Post-treatment Pain Scores- Likert Scale (Phase I)	As a secondary outcome, the post-treatment pain scores between the UV and non-UV exposures given on the first day the dose is given will be compared. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain	2 weeks
Secondary	Pain Scores of the UV and Non-UV Exposure (Phase II)	The pain scores were assessed using a Likert Scale. Pain will be assessed on an 11-point pain Likert scale where 0=no pain and 10=worst possible pain.	4 weeks post-treatment