Fibromyalgia, FMS
Conditions
Keywords
Circadian timing, Pain, Light
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).
Interventions
DEVICELight therapy B (Dim) via the Re-Timer®
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
DEVICELight therapy A (Bright) via the Re-Timer®
Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
Sponsors
National Institute of Nursing Research (NINR)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) | 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
| Measure | Time frame | Description |
|---|---|---|
| Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). | 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. |
| Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline) | 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. |
| Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline). | 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. |
Countries
United States
Participant flow
Pre-assignment details
60 participants were enrolled, and 57 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Light Therapy A (Bright) Via the Re-Timer® * 60 minutes/day
* For the first hour after waking
Light therapy A (bright light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. | 29 |
| Light Therapy B (Dim) Via the Re-Timer® * 60 minutes/day
* For the first hour after waking
Light therapy B (dim light) via the Re-Timer®: Subjects conducted light treatment in the mornings at home for one hour using Re-timer®. | 28 |
| Total | 57 |
Baseline characteristics
| Characteristic | Light Therapy A (Bright) Via the Re-Timer® | Light Therapy B (Dim) Via the Re-Timer® | Total |
|---|---|---|---|
| Age, Continuous | 41.3 Years STANDARD_DEVIATION 13.7 | 42.4 Years STANDARD_DEVIATION 13.1 | 41.8 Years STANDARD_DEVIATION 13.3 |
| Apnea-Hypopnea Index | 16.33 Events per hour STANDARD_DEVIATION 14.3 | 11.2 Events per hour STANDARD_DEVIATION 10.2 | 14.0 Events per hour STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 28 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 22 Participants | 48 Participants |
| Region of Enrollment United States | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Female | 28 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
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.
Time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Light Therapy A (Bright) Via the Re-Timer® | Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | Baseline (1 week) | 40.8 score on a scale | Standard Deviation 13.2 |
| Light Therapy A (Bright) Via the Re-Timer® | Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | Mid-Treatment (completed 2 Weeks following baseline) | 38.0 score on a scale | Standard Deviation 13.5 |
| Light Therapy A (Bright) Via the Re-Timer® | Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | Post Treatment (completed 4 Weeks following baseline) | 32.2 score on a scale | Standard Deviation 12.3 |
| Light Therapy B (Dim) Via the Re-Timer® | Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | Baseline (1 week) | 45.3 score on a scale | Standard Deviation 19 |
| Light Therapy B (Dim) Via the Re-Timer® | Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | Mid-Treatment (completed 2 Weeks following baseline) | 39.4 score on a scale | Standard Deviation 18.3 |
| Light Therapy B (Dim) Via the Re-Timer® | Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score | Post Treatment (completed 4 Weeks following baseline) | 32.7 score on a scale | Standard Deviation 19.2 |
Comparison: Test of between-arm difference at mid-treatment.p-value: 0.2895% CI: [-3.03, 10.64]Mixed Models Analysis
Comparison: Test of between-arm difference at end of treatment.p-value: 0.2195% CI: [-2.44, 11.4]Mixed Models Analysis
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.
Time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
Population: Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Light Therapy A (Bright) Via the Re-Timer® | Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Baseline (1 week) | 41.9 Degrees Celsius | Standard Deviation 3.3 |
| Light Therapy A (Bright) Via the Re-Timer® | Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Mid-Treatment (completed 2 weeks post-baseline) | 42.4 Degrees Celsius | Standard Deviation 3.5 |
| Light Therapy A (Bright) Via the Re-Timer® | Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Post-Treatment (completed 4 weeks post-baseline) | 42.7 Degrees Celsius | Standard Deviation 3.1 |
| Light Therapy B (Dim) Via the Re-Timer® | Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Baseline (1 week) | 41.9 Degrees Celsius | Standard Deviation 3.4 |
| Light Therapy B (Dim) Via the Re-Timer® | Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Mid-Treatment (completed 2 weeks post-baseline) | 41.8 Degrees Celsius | Standard Deviation 3.1 |
| Light Therapy B (Dim) Via the Re-Timer® | Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test | Post-Treatment (completed 4 weeks post-baseline) | 42.6 Degrees Celsius | Standard Deviation 3.3 |
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.
Time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
Population: Due to COVID-19's impact on in-person visits, close, in-person measurements were stopped. Only earlier participants' data is available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Light Therapy A (Bright) Via the Re-Timer® | Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Baseline (1 week) | 47.6 Degrees Celsius | Standard Deviation 1.8 |
| Light Therapy A (Bright) Via the Re-Timer® | Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Mid-Treatment (completed 2 weeks post-baseline) | 47.9 Degrees Celsius | Standard Deviation 1.6 |
| Light Therapy A (Bright) Via the Re-Timer® | Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Post-Treatment (completed 4 weeks post-baseline) | 47.8 Degrees Celsius | Standard Deviation 1.5 |
| Light Therapy B (Dim) Via the Re-Timer® | Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Baseline (1 week) | 46.2 Degrees Celsius | Standard Deviation 2.2 |
| Light Therapy B (Dim) Via the Re-Timer® | Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Mid-Treatment (completed 2 weeks post-baseline) | 46.2 Degrees Celsius | Standard Deviation 2 |
| Light Therapy B (Dim) Via the Re-Timer® | Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test | Post-Treatment (completed 4 weeks post-baseline) | 46.8 Degrees Celsius | Standard Deviation 2 |
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.
Time frame: Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Light Therapy A (Bright) Via the Re-Timer® | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Baseline (1 week) | 51.0 T-score | Standard Deviation 5.6 |
| Light Therapy A (Bright) Via the Re-Timer® | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Mid-Treatment (completed 2 weeks post-baseline) | 49.8 T-score | Standard Deviation 5.5 |
| Light Therapy A (Bright) Via the Re-Timer® | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Post-Treatment (completed 4 weeks post-baseline) | 47.9 T-score | Standard Deviation 4.4 |
| Light Therapy B (Dim) Via the Re-Timer® | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Baseline (1 week) | 51.6 T-score | Standard Deviation 5.4 |
| Light Therapy B (Dim) Via the Re-Timer® | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Mid-Treatment (completed 2 weeks post-baseline) | 50.4 T-score | Standard Deviation 5.8 |
| Light Therapy B (Dim) Via the Re-Timer® | Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score | Post-Treatment (completed 4 weeks post-baseline) | 49.6 T-score | Standard Deviation 6.2 |