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

University of Michigan1 site in 1 country60 target enrollmentJanuary 31, 2019

ConditionsFibromyalgia FMS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: University of Michigan
Enrollment: 60
Locations: 1
Primary Endpoint: Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

January 31, 2019

End Date

July 15, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Michigan

Responsible Party

Principal Investigator

Helen Burgess

Professor of Psychiatry

University of Michigan

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score

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

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.

Secondary Outcomes

Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test(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(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(Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).)