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

NCT ID: NCT02373189

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-02-28

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bright light

Participants received morning bright light.

Group Type: EXPERIMENTAL

Bright light

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen J Burgess, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AT008347

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13082603

Identifier Type: -

Identifier Source: org_study_id