Benefits of Tanning in Fibromyalgia Patients

NCT00447083 | Completed Results FDA Device

• 1 other identifier: II-CDR-Fibromyalgia
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

Tanning; Musculoskeletal; Fibromyalgia Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Post-treatment Pain Scores- Likert Scale (Phase I)

  2 weeks

• Pain Scores of the UV and Non-UV Exposure (Phase II)

  4 weeks post-treatment

Study Arms (4)

UVB First

EXPERIMENTAL

Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with UV. The dose of UV (time of exposure) will be progressively increased from 3 minutes to 9 minutes over the 6 visits to acclimate subjects to UV light. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive UVB tanning bed treatment first, then switch to the non-UVB treatment.

Device: UVB; Procedure: Non-UVB

Non-UVB First

PLACEBO COMPARATOR

Subjects with fibromyalgia will undergo 6 tanning sessions (3/week x 2 weeks) at which they will be exposed in tanning beds with non-UV bulbs. The time of exposure will be progressively increased from 3 minutes to 9 minutes over the 6 visits to mirror UVB treatment. Before and after every tanning session the subject will complete the pain questionnaire. Subjects in this group will be randomized to receive non-UVB tanning bed treatment first, then switch to the UVB treatment.

Device: UVB; Procedure: Non-UVB

UVB

EXPERIMENTAL

The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of UVB.

Device: UVB

Non-UVB

PLACEBO COMPARATOR

The subjects who complete the acclimation phase of the study will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of non-UVB exposure

Procedure: Non-UVB

Interventions

UVB DEVICE

UVB exposure by a tanning bed

Also known as: Ultraviolet Light

Non-UVB First; UVB; UVB First

Non-UVB PROCEDURE

Non-UVB exposure by a tanning bed

Non-UVB; Non-UVB First; UVB First

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Steve feldman, MD
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716-3775

Study Officials

• Steven R. Feldman, M.D., Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 14, 2007
• Study Start: May 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 13, 2018
• Results First Posted: November 13, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)