N/A N=57 Randomized Double-blind Supportive Care

Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

Fibromyalgia · FMS

Bottom Line

View on ClinicalTrials.gov: NCT03794908 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score — 40.8; 45.3; 38.0; 39.4 score on a scale — p=0.28

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Light therapy A (Bright) via the Re-Timer® (Device); Light therapy B (Dim) via the Re-Timer® (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score	40.8; 45.3; 38.0; 39.4; 32.2; 32.7	0.28
SECONDARY Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test	41.9; 41.9; 42.4; 41.8; 42.7; 42.6	—
SECONDARY Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test	47.6; 46.2; 47.9; 46.2; 47.8; 46.8	—
SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score	51.0; 51.6; 49.8; 50.4; 47.9; 49.6	—

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).

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03794908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.