Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

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

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 Overview

• Status: Completed
• Conditions: Fibromyalgia; FMS
• Intervention / Treatment: Device: Light therapy A (Bright) via the Re-Timer®; Device: Light therapy B (Dim) via the Re-Timer®

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Helen Burgess, University of Michigan

Publications and helpful links

Helpful Links

• Additional study information and application to apply for study

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Light; Circadian timing
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: HUM00151160; 1R21NR016930-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
• IPD Sharing Time Frame: After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
• IPD Sharing Access Criteria: Researchers requesting data will first have to sign a data sharing agreement, agreeing to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, electronically securing the data while in use, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, no use of the data for commercial purposes and proper acknowledgement of the data resource.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No