Benefits of Tanning in Fibromyalgia Patients

• Sponsor: Wake Forest University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00447083
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 4
• Duration (Months): 40
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome	Device: UVB; Procedure: Non-UVB	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of the Effect of Ultraviolet Light on Pain in Persons With Fibromyalgia Syndrome
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: UVB; UVB exposure by a tanning bed; Other Names: Ultraviolet Light ; Procedure: Non-UVB; Non-UVB exposure by a tanning bed
Placebo Comparator: 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.	Device: UVB; UVB exposure by a tanning bed; Other Names: Ultraviolet Light ; Procedure: Non-UVB; Non-UVB exposure by a tanning bed
Experimental: UVB 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; UVB exposure by a tanning bed; Other Names: Ultraviolet Light
Placebo Comparator: Non-UVB 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; Non-UVB exposure by a tanning bed

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University

Investigators

• Principal Investigator: Steven R. Feldman, M.D., Ph.D., Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT00447083
• Other Study ID Numbers: II-CDR-Fibromyalgia
• First Posted: Mar 14, 2007
• Last Update Posted: Nov 13, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Wake Forest University: Tanning; Musculoskeletal; Fibromyalgia Syndrome
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome

Study Results

Participant Flow

Arm/Group Title	Phase I - UVB First	Phase I - Non-UVB First	Phase II - UVB Exposure	Phase II -Non-UVB
Arm/Group Description	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	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	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.	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.
Period Title: Phase I
STARTED	10	9	0	0
COMPLETED	10	9	0	0
NOT COMPLETED	0	0	0	0
Period Title: Phase I
STARTED	0	0	8	8
COMPLETED	0	0	7	7
NOT COMPLETED	0	0	1	1

Baseline Characteristics

Arm/Group Title	UVB First	Non-UVB First	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	10	9	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	9 100%	19 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	10 100%	9 100%	19 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	9 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Pain Relief Success Rates (Phase I)
Description	Percentage of exposures that showed pain relief (2 point improvement in Likert scale) in the 11 point Likert scale.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UVB Exposure	Non-UVB Exposure
Arm/Group Description	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	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
Measure Participants	19	19
Number [percentage of exposures with relief]	33	16

2. Primary Outcome

Title	Pain Score- Likert Scale(Phase II)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UVB Exposure	Non-UVB
Arm/Group Description	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.	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
Measure Participants	7	7
Mean (Standard Error) [score on a scale]	4.55 (0.29)	4.95 (0.24)

3. Secondary Outcome

Title	Post-treatment Pain Scores- Likert Scale (Phase I)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UVB Exposure	Non-UVB Exposure
Arm/Group Description	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	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
Measure Participants	19	19
Mean (Standard Deviation) [score on a scale]	4.89 (2.56)	5.21 (2.64)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UVB Exposure	Non-UVB
Arm/Group Description	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.	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
Measure Participants	7	7
Mean (Standard Error) [score on a scale]	4.65 (.56)	5.54 (.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UVB Exposure, Non-UVB Exposure
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.1811
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	UVB Exposure		Non-UVB
Arm/Group Description	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.		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
All Cause Mortality
	UVB Exposure		Non-UVB
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	UVB Exposure		Non-UVB
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	UVB Exposure		Non-UVB
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.