Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome
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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
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: Light therapy A via the Re-Timer®
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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®
|
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® |
- 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.
- 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.
- 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.
- 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".

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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).

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
Contact: FibroLight Study | 734-647-6657 | fibrolight@med.umich.edu |
United States, Michigan | |
The University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Principal Investigator: Helen Burgess, PhD |
Principal Investigator: | Helen Burgess | University of Michigan |
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. |
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 |
Circadian timing Pain Light |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |