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Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT03794908
Collaborator
National Institute of Nursing Research (NINR) (NIH)
57
Enrollment
1
Location
2
Arms
29.4
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Light therapy A via the Re-Timer®
  • Device: Light therapy B via the Re-Timer®
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
The outcome assessors and participants will be blinded to condition. The PI and lab manager will remain unblinded, and perform the fidelity and side effects assessments. Participants are asked and reminded throughout the study to only speak about their light treatment with either the PI or lab manager.
Primary Purpose:
Supportive Care
Official Title:
Bright Light Treatment at Home to Improve Symptom Management of Fibromyalgia Syndrome
Actual Study Start Date :
Jan 31, 2019
Actual Primary Completion Date :
Jul 15, 2021
Actual Study Completion Date :
Jul 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Light therapy A via the Re-Timer®

60 minutes/day For the first hour after waking

Device: Light therapy A 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 via the Re-Timer®

    60 minutes/day For the first hour after waking

    Device: Light therapy B via the Re-Timer®
    Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
    Other Names:
  • Re-Timer®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fibromyalgia Impact Questionnaire, Revised (FIQ-R) score [Up to 5 weeks]

      The FIQR consists of 21 questions. Each question has 11 boxes similar to a visual analog scale. Questions cover the difficulty associated with various physical activities and the severity of symptoms.

    Secondary Outcome Measures

    1. Heat pain threshold assessed by the heat pain sensitivity test [Up to 5 weeks]

      Pain threshold will be assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol.

    2. Heat pain tolerance assessed by the heat pain sensitivity test [Up to 5 weeks]

      Pain tolerance will be assessed during a heat pain sensitivity task using a Medoc TSAII NeuroSensory Analyzer and an ascending method of limits protocol.

    3. Patient Reported Outcomes Measurement Information System (PROMIS) pain intensity score [Up to 5 weeks]

      The PROMIS Pain Intensity instrument assesses how much a person hurts. Scores range from 1 "had no pain" to 5 "very severe".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan
    • National Institute of Nursing Research (NINR)

    Investigators

    • Principal Investigator: Helen Burgess, University of Michigan

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Helen Burgess, Professor of Psychiatry, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT03794908
    Other Study ID Numbers:
    • HUM00151160
    • 1R21NR016930-01A1
    First Posted:
    Jan 7, 2019
    Last Update Posted:
    Jul 23, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Helen Burgess, Professor of Psychiatry, University of Michigan
    Circadian timing
    Pain
    Light
    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes

    Study Results

    No Results Posted as of Jul 23, 2021