Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

University of Michigan60 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia FMS

Interventions

Light therapy A (Bright) via the Re-Timer®DEVICE

Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.

Light therapy B (Dim) via the Re-Timer®DEVICE

Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).

Data from ClinicalTrials.gov

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