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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT008347 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright light | Experimental | Participants received morning bright light. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Outcomes Measurement Information System Pain Intensity | How intense is the pain? 0-100 Likert Scale. 0 = no pain; 100 = worst pain | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 0 - 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen J Burgess, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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US military veterans with chronic low back pain
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic information on average age of participants. Lowest age available for each participant 18 and highest age 65. We describe the mean age of our participants. There is no subscale data or better or worse for this description. |
| 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 | Patient Reported Outcomes Measurement Information System Pain Intensity | How intense is the pain? 0-100 Likert Scale. 0 = no pain; 100 = worst pain | US military veterans | Posted | Mean | Standard Deviation | units on a scale | 1 day |
|
1 day
Procedures were deemed low risk.
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Burns | Rush University Medical Center | 13129420379 | john_burns@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 23, 2022 | Dec 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 23, 2022 | Dec 23, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2016 | Nov 20, 2023 | ICF_002.pdf |
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|
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Information gathered on two different sexes of our participants. Male and Female descriptors used with totals listed for percentages of each category. This is not a scale measurement just direct information on participants. No better or worse outcomes for this and no subscale. | Count of Participants | Participants |
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| Race (NIH/OMB) | Breakout of different race descriptors for participants. There is no subscale and no better or worse metrics used. Use of commonly used race descriptors for participants used. | Count of Participants | Participants |
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| Region of Enrollment | Measurement to determine different locations of participants per country location. There is no subscale and no better or worse scale. | Number | participants |
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| pain intensity | PROMIS Pain Intensity Scale. The first two items in the Pain Intensity item bank assess pain intensity utilizing a 7-day recall period (items include the phrase "the past 7 days") while the last item asks patient to rate their pain intensity "right now." The Pain Intensity instrument is available for adults (ages 18+). A Numerical Rating Scale, patients are asked to circle the number between 0 and 100 that fits best to their pain intensity. "0" represents 'no pain at all' whereas "100" represents 'the worst pain ever possible'. Likert scale used 0-100 with median at 50. | Mean | Standard Deviation | units on a scale |
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| 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." | US military veterans | Posted | Mean | Standard Deviation | seconds | 0 - 5 minutes |
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| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
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