Trial Outcomes & Findings for Bright Light Treatment At Home To Manage Chronic Pain In U.S. Veterans (NCT NCT02373189)

NCT ID: NCT02373189

Last Updated: 2023-12-19

Results Overview

How intense is the pain? 0-100 Likert Scale. 0 = no pain; 100 = worst pain

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2023-12-19

Participant Flow

Participant milestones

Measure	Open Trial of Bright Light Treatment for Chronic Pain Bright light: The purpose of this R34 Pilot and Feasibility study is to develop a morning bright light treatment to help manage chronic pain and improve PTSD symptoms, mood, and sleep in US veterans. Veterans will have 7 baseline days at home, followed by a baseline pain sensitivity assessment and baseline home circadian phase assessment (dim light melatonin onset). Following an instructional home visit, patients will then self-administer morning bright light treatment for 6 days, followed by reassessments of pain sensitivity and home circadian phase. This will be repeated after a further 7 days of morning bright light treatment. The Patient Reported Outcomes Measurement Information System (PROMIS) will also be administered at every lab visit. Additionally, pain and mood (electronic diaries) and sleep (wrist actigraphy) will be assessed daily throughout baseline and treatment. Pain, mood and sleep will also be self-reported daily during a 1 month follow up after cessation of light treatment.
Overall Study STARTED	37
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bright Light Treatment At Home To Manage Chronic Pain In U.S. Veterans

Baseline characteristics by cohort

Measure	Open Trial of Bright Light Treatment for Chronic Pain n=37 Participants Bright light: The purpose of this R34 Pilot and Feasibility study is to develop a morning bright light treatment to help manage chronic pain and improve PTSD symptoms, mood, and sleep in US veterans. Veterans will have 7 baseline days at home, followed by a baseline pain sensitivity assessment and baseline home circadian phase assessment (dim light melatonin onset). Following an instructional home visit, patients will then self-administer morning bright light treatment for 6 days, followed by reassessments of pain sensitivity and home circadian phase. This will be repeated after a further 7 days of morning bright light treatment. The Patient Reported Outcomes Measurement Information System (PROMIS) will also be administered at every lab visit. Additionally, pain and mood (electronic diaries) and sleep (wrist actigraphy) will be assessed daily throughout baseline and treatment. Pain, mood and sleep will also be self-reported daily during a 1 month follow up after cessation of light treatment.
Age, Continuous	48.4 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female · Female	10 Participants n=5 Participants
Sex: Female, Male Female · Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants
pain intensity	47.02 units on a scale STANDARD_DEVIATION 6 • n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: US military veterans

How intense is the pain? 0-100 Likert Scale. 0 = no pain; 100 = worst pain

Outcome measures

Measure

Open Trial of Bright Light Treatment for Chronic Pain n=25 Participants Bright light: The purpose of this R34 Pilot and Feasibility study is to develop a morning bright light treatment to help manage chronic pain and improve PTSD symptoms, mood, and sleep in US veterans. Veterans will have 7 baseline days at home, followed by a baseline pain sensitivity assessment and baseline home circadian phase assessment (dim light melatonin onset). Following an instructional home visit, patients will then self-administer morning bright light treatment for 6 days, followed by reassessments of pain sensitivity and home circadian phase. This will be repeated after a further 7 days of morning bright light treatment. The Patient Reported Outcomes Measurement Information System (PROMIS) will also be administered at every lab visit. Additionally, pain and mood (electronic diaries) and sleep (wrist actigraphy) will be assessed daily throughout baseline and treatment. Pain, mood and sleep will also be self-reported daily during a 1 month follow up after cessation of light treatment.

Patient Reported Outcomes Measurement Information System Pain Intensity

48.84 units on a scale Standard Deviation 6.30

SECONDARY outcome

Timeframe: 0 - 5 minutes

Population: US military veterans

Laboratory testing. Subject placed hand in ice water until discomfort became intolerable. Elapsed time between immersion and removal of hand in seconds was defined as "tolerance."

Outcome measures

Measure

Open Trial of Bright Light Treatment for Chronic Pain n=25 Participants Bright light: The purpose of this R34 Pilot and Feasibility study is to develop a morning bright light treatment to help manage chronic pain and improve PTSD symptoms, mood, and sleep in US veterans. Veterans will have 7 baseline days at home, followed by a baseline pain sensitivity assessment and baseline home circadian phase assessment (dim light melatonin onset). Following an instructional home visit, patients will then self-administer morning bright light treatment for 6 days, followed by reassessments of pain sensitivity and home circadian phase. This will be repeated after a further 7 days of morning bright light treatment. The Patient Reported Outcomes Measurement Information System (PROMIS) will also be administered at every lab visit. Additionally, pain and mood (electronic diaries) and sleep (wrist actigraphy) will be assessed daily throughout baseline and treatment. Pain, mood and sleep will also be self-reported daily during a 1 month follow up after cessation of light treatment.

Pain Tolerance

187.88 seconds Standard Deviation 160.13

Adverse Events

Open Trial of Bright Light Treatment for Chronic Pain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Burns

Rush University Medical Center

Phone: 13129420379

Email: john_burns@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place