Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

Not Applicable

Completed

• Conditions: Fibromyalgia; FMS
• Interventions: Device: Light therapy A (Bright) via the Re-Timer®; Device: Light therapy B (Dim) via the Re-Timer®

• Registration Number: NCT03794908
• Lead Sponsor: University of Michigan

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Study Start: 2019-01-31
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Results First Submitted: 2022-07-14
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-27
• Last Update Submitted: 2022-09-27
• Results First Posted: 2022-10-05
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Meet criteria for Fibromyalgia syndrome (FMS)

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light therapy A (Bright) via the Re-Timer®	Light therapy A (Bright) via the Re-Timer®	* 60 minutes/day * For the first hour after waking
Light therapy B (Dim) via the Re-Timer®	Light therapy B (Dim) via the Re-Timer®	* 60 minutes/day * For the first hour after waking

Primary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score	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 Outcome Measures

Name	Time	Method
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)	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.
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).	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.
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).	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.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States