Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794908
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 6, 2021
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Helen Burgess, University of Michigan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Fibromyalgia FMS Device: Light therapy A via the Re-Timer® Device: Light therapy B via the Re-Timer® Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : January 31, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Re-Timer®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire, Revised (FIQ-R) score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794908


Contacts
Layout table for location contacts
Contact: FibroLight Study 734-647-6657 fibrolight@med.umich.edu

Locations
Layout table for location information
United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Helen Burgess, PhD         
Sponsors and Collaborators
University of Michigan
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Helen Burgess University of Michigan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Helen Burgess, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT03794908    
Other Study ID Numbers: HUM00151160
1R21NR016930-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
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.

Layout table for additional information
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, University of Michigan:
Circadian timing
Pain
Light
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases