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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373189
Recruitment Status : Active, not recruiting
First Posted : February 26, 2015
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Helen Burgess, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE February 16, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date March 10, 2020
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Pain intensity [ Time Frame: 53 days ]
How intense is the pain?
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
Pain sensitivity [ Time Frame: 23 days ]
Laboratory testing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bright Light Treatment At Home To Manage Chronic Pain In U.S. Veterans
Official Title  ICMJE Not Provided
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: Bright light
Intervention: Device: Bright light
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2015)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373189
Other Study ID Numbers  ICMJE 13082603
R34AT008347 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Helen Burgess, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Helen J Burgess, PhD Rush University Medical Center
PRS Account Rush University Medical Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP