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Completed

NCT Number: NCT03794908

Light Treatment 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).

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Key information

Conditions

Fibromyalgia FMS Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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®.

Other names: 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®.

Other names: Re-Timer®

Primary outcomes

  1. 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

  1. Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test

    Time frame: 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.

  2. Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test

    Time frame: 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.

  3. Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2019
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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