Back to resultsLight Treatment to Improve Symptom Management of Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia, FMS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light therapy A (Bright) via the Re-Timer®
Light therapy B (Dim) via the Re-Timer®
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia focused on measuring Circadian timing, Pain, Light
Eligibility 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).
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Light therapy A (Bright) via the Re-Timer®
Light therapy B (Dim) via the Re-Timer®
Arm Description
60 minutes/day For the first hour after waking
60 minutes/day For the first hour after waking
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
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
Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test
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
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
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.
Full Information
NCT ID
NCT03794908
First Posted
January 3, 2019
Last Updated
September 27, 2022
Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT03794908
Brief Title
Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome
Official Title
Bright Light Treatment at Home to Improve Symptom Management of Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
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
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, FMS
Keywords
Circadian timing, Pain, Light
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The outcome assessors and participants were blinded to condition. The PI and lab manager remained unblinded, and performed the fidelity and side-effects assessments. Participants were asked and reminded throughout the study to only speak about their light treatment with either the PI or lab manager.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light therapy A (Bright) via the Re-Timer®
Arm Type
Experimental
Arm Description
60 minutes/day
For the first hour after waking
Arm Title
Light therapy B (Dim) via the Re-Timer®
Arm Type
Active Comparator
Arm Description
60 minutes/day
For the first hour after waking
Intervention Type
Device
Intervention Name(s)
Light therapy A (Bright) via the Re-Timer®
Other Intervention Name(s)
Re-Timer®
Intervention Description
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
Intervention Type
Device
Intervention Name(s)
Light therapy B (Dim) via the Re-Timer®
Other Intervention Name(s)
Re-Timer®
Intervention Description
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
Description
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.
Time Frame
Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
Secondary Outcome Measure Information:
Title
Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test
Description
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.
Time Frame
Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
Title
Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test
Description
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.
Time Frame
Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
Title
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score
Description
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.
Time Frame
Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Burgess
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
IPD Sharing Time Frame
After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
IPD Sharing 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.
Links:
URL
https://is.gd/Fibrolight
Description
Additional study information and application to apply for study
Learn more about this trial
Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome
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