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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02373189
Enrollment
37
Registered
2015-02-26
Start date
2014-08-31
Completion date
2018-02-28
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Brief summary

Nearly 50% of U.S. veterans report they experience pain on a regular basis. This chronic pain often co-occurs with other disorders including post-traumatic stress disorder (PTSD), depression, anxiety and insomnia. A common approach to treating chronic pain is opioid analgesics, which are not always effective, and increasingly associated with abuse and misuse. Thus, there is an urgent need to develop readily available, safe, and practical complementary nonpharmacological approaches to manage chronic pain in U.S. veterans. Chronic pain is a multidimensional phenomenon, inter-related with many factors, including negative mood and poor sleep. The central circadian clock, in the suprachiasmatic nucleus in the hypothalamus, is well recognized to regulate both mood and sleep, and even small delays (shifts later) in circadian/sleep timing are associated with depression and disrupted sleep. These results suggests that later circadian/sleep timing may be a modifiable risk factor for pain. Thus, a self-administered morning bright light treatment at home may be a potentially efficacious adjunctive strategy for managing chronic pain. This R34 grant will develop a morning bright light treatment to help manage chronic pain and improve PTSD symptoms, depression, anxiety and sleep in U.S. veterans. Patients will have 7 baseline days at home, followed by a baseline pain sensitivity assessment and 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 circadian phase. Assessments will be repeated after another 7 days of morning bright light treatment. Pain, mood and sleep (wrist actigraphy) will be assessed daily throughout baseline and treatment. Pain, mood and sleep will also be rated by veterans daily during a 1 month follow up after cessation of light treatment. This study will determine the feasibility, acceptability and efficacy of bright light treatment in a sample of U.S. veterans experiencing chronic low back pain.

Detailed description

Almost 50% of U.S. veterans report they experience pain on a regular basis. This chronic pain often co-occurs with other disorders including post-traumatic stress disorder (PTSD), depression, anxiety and insomnia. A common approach to treating chronic pain is opioid analgesics, which are not always effective, and increasingly associated with abuse and misuse. Thus, there is an urgent need to develop readily available, safe, and practical complementary nonpharmacological approaches to manage chronic pain in U.S. veterans. Chronic pain is a multidimensional phenomenon, inter-related with many factors, including negative mood and poor sleep. The central circadian clock, in the suprachiasmatic nucleus in the hypothalamus, is well recognized to regulate both mood and sleep, and even small delays (shifts later) in circadian/sleep timing are associated with depression and disrupted sleep. These results suggests that later circadian/sleep timing may be a modifiable risk factor for pain. Thus, a self-administered morning bright light treatment at home may be a potentially efficacious adjunctive strategy for managing chronic pain. This R34 grant will develop a morning bright light treatment to help manage chronic pain and improve PTSD symptoms, depression, anxiety and sleep in U.S. veterans. Patients will have 7 baseline days at home, followed by a baseline pain sensitivity assessment and 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 circadian phase. Assessments will be repeated after another 7 days of morning bright light treatment. Pain, mood and sleep (wrist actigraphy) will be assessed daily throughout baseline and treatment. Pain, mood and sleep will also be rated by veterans daily during a 1 month follow up after cessation of light treatment. This study will determine the feasibility, acceptability and efficacy of bright light treatment in a sample of U.S. veterans experiencing chronic low back pain.

Interventions

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.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. U.S. veteran 2. musculoskeletal pain of the lower back and/or leg pain stemming from degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory) verified with written confirmation from physician/medical record 3. age between 18 and 70 years 4. live within 1.5 hours drive of Rush University Medical Center

Exclusion criteria

1. inability to understand English well enough to complete questionnaires or to participate; 2. unable to travel to the lab

Design outcomes

Primary

MeasureTime frameDescription
Patient Reported Outcomes Measurement Information System Pain Intensity1 dayHow intense is the pain? 0-100 Likert Scale. 0 = no pain; 100 = worst pain

Secondary

MeasureTime frameDescription
Pain Tolerance0 - 5 minutesLaboratory 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
37
Total37

Baseline characteristics

CharacteristicOpen Trial of Bright Light Treatment for Chronic Pain
Age, Continuous48.4 years
STANDARD_DEVIATION 14.1
pain intensity47.02 units on a scale
STANDARD_DEVIATION 6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
22 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
13 Participants
Region of Enrollment
United States
37 participants
Sex: Female, Male
Female
Female
10 Participants
Sex: Female, Male
Female
Male
27 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 37
other
Total, other adverse events
0 / 37
serious
Total, serious adverse events
0 / 37

Outcome results

Primary

Patient Reported Outcomes Measurement Information System Pain Intensity

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

Time frame: 1 day

Population: US military veterans

ArmMeasureValue (MEAN)Dispersion
Open Trial of Bright Light Treatment for Chronic PainPatient Reported Outcomes Measurement Information System Pain Intensity48.84 units on a scaleStandard Deviation 6.3
p-value: 0.05paired t-test
Secondary

Pain Tolerance

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.

Time frame: 0 - 5 minutes

Population: US military veterans

ArmMeasureValue (MEAN)Dispersion
Open Trial of Bright Light Treatment for Chronic PainPain Tolerance187.88 secondsStandard Deviation 160.13
p-value: 0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026