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Benefits of Tanning in Fibromyalgia Patients

Primary Purpose

Fibromyalgia Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

UVB

Non-UVB

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Tanning, Musculoskeletal, Fibromyalgia Syndrome

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

UVB First

Non-UVB First

UVB

Non-UVB

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT00447083

First Posted

March 13, 2007

Last Updated

October 11, 2018

Sponsor

Wake Forest University

1. Study Identification

Unique Protocol Identification Number

NCT00447083

Brief Title

Benefits of Tanning in Fibromyalgia Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia Syndrome

Keywords

Tanning, Musculoskeletal, Fibromyalgia Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UVB First

Arm Type

Experimental

Arm Description

Arm Title

Non-UVB First

Arm Type

Placebo Comparator

Arm Description

Arm Title

UVB

Arm Type

Experimental

Arm 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.

Arm Title

Non-UVB

Arm Type

Placebo Comparator

Arm 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 non-UVB exposure

Intervention Type

Device

Intervention Name(s)

UVB

Other Intervention Name(s)

Ultraviolet Light

Intervention Description

UVB exposure by a tanning bed

Intervention Type

Procedure

Intervention Name(s)

Non-UVB

Intervention Description

Non-UVB exposure by a tanning bed

Primary Outcome Measure Information:

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

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

2 weeks

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven R. Feldman, M.D., Ph.D.

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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