Fibromyalgia Syndrome
Conditions
Keywords
Tanning, Musculoskeletal, Fibromyalgia Syndrome
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.
Interventions
PROCEDURENon-UVB
Non-UVB exposure by a tanning bed
DEVICEUVB
UVB exposure by a tanning bed
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief Success Rates (Phase I) | 2 weeks | Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale. |
| Pain Score- Likert Scale(Phase II) | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment Pain Scores- Likert Scale (Phase I) | 2 weeks | 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 |
| Pain Scores of the UV and Non-UV Exposure (Phase II) | 4 weeks post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UVB First 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.
UVB: UVB exposure by a tanning bed | 10 |
| Non-UVB First 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.
UVB: UVB exposure by a tanning bed | 9 |
| Total | 19 |
Baseline characteristics
| Characteristic | Non-UVB First | Total | UVB First |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 19 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 19 participants | 10 participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UVB Exposure | Pain Relief Success Rates (Phase I) | 33 percentage of exposures with relief |
| Non-UVB Exposure | Pain Relief Success Rates (Phase I) | 16 percentage of exposures with relief |
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UVB Exposure | Pain Score- Likert Scale(Phase II) | 4.55 score on a scale | Standard Error 0.29 |
| Non-UVB Exposure | Pain Score- Likert Scale(Phase II) | 4.95 score on a scale | Standard Error 0.24 |
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.
Time frame: 4 weeks post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UVB Exposure | Pain Scores of the UV and Non-UV Exposure (Phase II) | 4.65 score on a scale | Standard Error 0.56 |
| Non-UVB Exposure | Pain Scores of the UV and Non-UV Exposure (Phase II) | 5.54 score on a scale | Standard Error 0.32 |
p-value: 0.1811t-test, 2 sided
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
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UVB Exposure | Post-treatment Pain Scores- Likert Scale (Phase I) | 4.89 score on a scale | Standard Deviation 2.56 |
| Non-UVB Exposure | Post-treatment Pain Scores- Likert Scale (Phase I) | 5.21 score on a scale | Standard Deviation 2.64 |