Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect a morning light treatment has on improving physical function, pain intensity, and pain sensitivity in people with fibromyalgia syndrome (FMS).

Official Title
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Bright Light Treatment at Home to Improve Symptom Management of Fibromyalgia Syndrome

Conditions
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Fibromyalgia, FMS

Intervention / Treatment
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* Device: Light therapy A (Bright) via the Re-Timer®
* Device: Light therapy B (Dim) via the Re-Timer®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Meet criteria for Fibromyalgia syndrome (FMS) Exclusion Criteria: Significant chronic disease Severe hearing or memory problems Pending medical leave applications at workplace Current pregnancy, breastfeeding, or actively trying to get pregnant Night work or travel outside the eastern time zone within 1 month of the study Other research participation Frequent number of special events during study period (weddings, concerts, exams, etc).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light therapy A (Bright) via the Re-Timer®<br>60 minutes/day For the first hour after waking | Device: Light therapy A (Bright) via the Re-Timer®<br>* Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.<br>* Other names: Re-Timer®;|
| Active Comparator: Light therapy B (Dim) via the Re-Timer®<br>60 minutes/day For the first hour after waking | Device: Light therapy B (Dim) via the Re-Timer®<br>* Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.<br>* Other names: Re-Timer®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | The FIQR consisted of 21 questions. Each question had 11 boxes similar to a visual analog scale. Questions covered the difficulty associated with various physical activities and the severity of symptoms. The score for the questions was on a scale from 0 - 100, where lower scores represented better functional status. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Pain threshold was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The threshold was the temperature (in degrees Celsius) at which the participant reported the stimulus felt painful. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) | 
| Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Pain tolerance was assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol. The tolerance was the temperature (in degrees Celsius) at which the participant reported the stimulus was so painful that they had to stop. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). | 
| Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Pain was assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a short form, which assesses worst and average pain in the past 7 days (1=no pain to 5=very severe) and current level of pain (1=no pain to 5= very severe). Scores were summed and converted to a T score metric (mean ±SD, 50 ±10); higher scores indicate more pain. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circadian timing, Pain, Light