Trial Outcomes & Findings for Benefits of Tanning in Fibromyalgia Patients (NCT NCT00447083)
NCT ID: NCT00447083
Last Updated: 2018-11-13
Results Overview
Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
2 weeks
Results posted on
2018-11-13
Participant Flow
Participant milestones
| Measure |
Phase I - 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
|
Phase I - 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
|
Phase II - UVB Exposure
Part of the subjects who complete the acclimation phase of the study ( Phase I) will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of UVB.
|
Phase II -Non-UVB
Part of the subjects who complete the acclimation phase of the study ( Phase I) will then be randomized to 3 times/week treatments for 6 weeks with a fixed dose (10 min) of non-UVB exposure in Phase II.
|
|---|---|---|---|---|
|
Phase I
STARTED
|
10
|
9
|
0
|
0
|
|
Phase I
COMPLETED
|
10
|
9
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
8
|
8
|
|
Phase II
COMPLETED
|
0
|
0
|
7
|
7
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
UVB First
n=10 Participants
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
|
Non-UVB First
n=9 Participants
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
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
9 Participants
n=9 Participants
|
19 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
9 participants
n=9 Participants
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPercentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.
Outcome measures
| Measure |
UVB Exposure
n=19 Participants
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 received UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
Non-UVB Exposure
n=19 Participants
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 received non-UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
|---|---|---|
|
Pain Relief Success Rates (Phase I)
|
33 percentage of exposures with relief
|
16 percentage of exposures with relief
|
PRIMARY outcome
Timeframe: 6 weeksPain 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.
Outcome measures
| Measure |
UVB Exposure
n=7 Participants
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 received UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
Non-UVB Exposure
n=7 Participants
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 received non-UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
|---|---|---|
|
Pain Score- Likert Scale(Phase II)
|
4.55 score on a scale
Standard Error 0.29
|
4.95 score on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: 2 weeksAs 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
Outcome measures
| Measure |
UVB Exposure
n=19 Participants
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 received UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
Non-UVB Exposure
n=19 Participants
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 received non-UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
|---|---|---|
|
Post-treatment Pain Scores- Likert Scale (Phase I)
|
4.89 score on a scale
Standard Deviation 2.56
|
5.21 score on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: 4 weeks post-treatmentThe 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.
Outcome measures
| Measure |
UVB Exposure
n=7 Participants
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 received UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
Non-UVB Exposure
n=7 Participants
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 received non-UVB tanning bed treatment.
UVB: UVB exposure by a tanning bed
|
|---|---|---|
|
Pain Scores of the UV and Non-UV Exposure (Phase II)
|
4.65 score on a scale
Standard Error .56
|
5.54 score on a scale
Standard Error .32
|
Adverse Events
UVB Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-UVB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steve feldman, MD
Wake Forest University Health Sciences
Phone: 336-716-3775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place