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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NR016930-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light therapy A (Bright) via the Re-Timer® | Experimental |
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| Light therapy B (Dim) via the Re-Timer® | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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®. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) |
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Inclusion Criteria:
• Meet criteria for Fibromyalgia syndrome (FMS)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Burgess | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Label | URL |
|---|---|
| Additional study information and application to apply for study | View source |
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The researchers are open to sharing data by any appropriate mechanism indicated by NIH program staff.
After scientific papers are accepted for publication and the data will be available for 7 years after study completion.
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.
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60 participants were enrolled, and 57 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Light Therapy A (Bright) Via the Re-Timer® |
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. |
| FG001 | Light Therapy B (Dim) Via the Re-Timer® |
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Light Therapy A (Bright) Via the Re-Timer® |
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. |
| BG001 | Light Therapy B (Dim) Via the Re-Timer® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) |
|
Through study completion, an average of 5 weeks.
Systematic Assessment for Treatment Emergent Events (SAFTEE) Questionnaire, a self-reported measure of physical and emotional symptoms experienced in the past week.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Light Therapy A (Bright) Via the Re-Timer® |
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen Burgess | University of Michigan | 734-615-8303 | bhelen@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2021 | Jun 30, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2021 | Jul 16, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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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.
|
| 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®. |
|
|
| 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. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). |
| 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. | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). |
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Apnea-Hypopnea Index | Number of pauses in breath per hour during nighttime sleep. | Participants who elected not to wear the watchPAT device were not included in the analysis. | Mean | Standard Deviation | Events per hour |
|
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. |
|
|
|
| Secondary | 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. | Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) |
|
|
|
| Secondary | 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. | Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available. | Posted | Mean | Standard Deviation | Degrees Celsius | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T-score | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Light Therapy B (Dim) Via the Re-Timer® |
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Post-Treatment (completed 4 weeks post-baseline) |
|
| Post-Treatment (completed 4 weeks post-baseline) |
|
| Post-Treatment (completed 4 weeks post-baseline) |
|