Trial Outcomes & Findings for Light Treatment to Improve Symptom Management of Fibromyalgia Syndrome (NCT NCT03794908)
NCT ID: NCT03794908
Last Updated: 2022-10-05
Results Overview
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.
COMPLETED
NA
60 participants
Baseline (1 week), Mid-Treatment (2 weeks post-baseline), Post-Treatment (4 weeks post-baseline)
2022-10-05
Participant Flow
60 participants were enrolled, and 57 participants were randomized.
Participant milestones
| Measure |
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®.
|
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®.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
Began Use of Re-Timer
|
27
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants who elected not to wear the watchPAT device were not included in the analysis.
Baseline characteristics by cohort
| Measure |
Light Therapy A (Bright) Via the Re-Timer®
n=29 Participants
* 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®.
|
Light Therapy B (Dim) Via the Re-Timer®
n=28 Participants
* 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®.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 Years
STANDARD_DEVIATION 13.7 • n=29 Participants
|
42.4 Years
STANDARD_DEVIATION 13.1 • n=28 Participants
|
41.8 Years
STANDARD_DEVIATION 13.3 • n=57 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=29 Participants
|
27 Participants
n=28 Participants
|
55 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
3 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=29 Participants
|
28 Participants
n=28 Participants
|
54 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=29 Participants
|
3 Participants
n=28 Participants
|
4 Participants
n=57 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=29 Participants
|
22 Participants
n=28 Participants
|
48 Participants
n=57 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=29 Participants
|
2 Participants
n=28 Participants
|
2 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=57 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=29 Participants
|
28 Participants
n=28 Participants
|
57 Participants
n=57 Participants
|
|
Apnea-Hypopnea Index
|
16.33 Events per hour
STANDARD_DEVIATION 14.3 • n=29 Participants • Participants who elected not to wear the watchPAT device were not included in the analysis.
|
11.2 Events per hour
STANDARD_DEVIATION 10.2 • n=25 Participants • Participants who elected not to wear the watchPAT device were not included in the analysis.
|
14.0 Events per hour
STANDARD_DEVIATION 12.7 • n=54 Participants • Participants who elected not to wear the watchPAT device were not included in the analysis.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Light Therapy A (Bright) Via the Re-Timer®
n=29 Participants
* 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®.
|
Light Therapy B (Dim) Via the Re-Timer®
n=28 Participants
* 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®.
|
|---|---|---|
|
Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
Baseline (1 week)
|
40.8 score on a scale
Standard Deviation 13.2
|
45.3 score on a scale
Standard Deviation 19.0
|
|
Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
Mid-Treatment (completed 2 Weeks following baseline)
|
38.0 score on a scale
Standard Deviation 13.5
|
39.4 score on a scale
Standard Deviation 18.3
|
|
Fibromyalgia Impact Questionnaire, Revised (FIQ-R) Score
Post Treatment (completed 4 Weeks following baseline)
|
32.2 score on a scale
Standard Deviation 12.3
|
32.7 score on a scale
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Light Therapy A (Bright) Via the Re-Timer®
n=16 Participants
* 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®.
|
Light Therapy B (Dim) Via the Re-Timer®
n=14 Participants
* 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®.
|
|---|---|---|
|
Heat Pain Threshold Assessed by the Heat Pain Sensitivity Test
Baseline (1 week)
|
41.9 Degrees Celsius
Standard Deviation 3.3
|
41.9 Degrees Celsius
Standard Deviation 3.4
|
|
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
|
41.8 Degrees Celsius
Standard Deviation 3.1
|
|
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
|
42.6 Degrees Celsius
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Light Therapy A (Bright) Via the Re-Timer®
n=16 Participants
* 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®.
|
Light Therapy B (Dim) Via the Re-Timer®
n=14 Participants
* 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®.
|
|---|---|---|
|
Heat Pain Tolerance Assessed by the Heat Pain Sensitivity Test
Baseline (1 week)
|
47.6 Degrees Celsius
Standard Deviation 1.8
|
46.2 Degrees Celsius
Standard Deviation 2.2
|
|
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
|
46.2 Degrees Celsius
Standard Deviation 2.0
|
|
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
|
46.8 Degrees Celsius
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Light Therapy A (Bright) Via the Re-Timer®
n=29 Participants
* 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®.
|
Light Therapy B (Dim) Via the Re-Timer®
n=28 Participants
* 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®.
|
|---|---|---|
|
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
|
49.6 T-score
Standard Deviation 6.2
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score
Baseline (1 week)
|
51.0 T-score
Standard Deviation 5.6
|
51.6 T-score
Standard Deviation 5.4
|
|
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
|
50.4 T-score
Standard Deviation 5.8
|
Adverse Events
Light Therapy A (Bright) Via the Re-Timer®
Light Therapy B (Dim) Via the Re-Timer®
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place