Clinical Trial 45436

Baltimore, MD 21224


Summary:

The purpose of this research study is to examine the association of sleep, pain, and medication use in patients with chronic low back pain. This study will help identify behavioral and biological factors that contribute to chronic pain disorders. The study will be conducted in three parts. Part 1 involves a Baseline Session, which includes screening questionnaires and a teleconsent meeting. Part 2 involves a device training session, followed by a monitoring period of 14 days during which participants will receive assessments through a smartphone app multiple times a day. Part 3 consists of a Follow-Up Session, which includes a battery of questionnaires and another period of 14 days during which participants will receive daily assessments through the smartphone app. You may be compensated up to $515 upon completion of all study related tasks and visits.


Qualified Participants Must:

• Inclusion Criteria.

  1. 21-75 years old
  2. report low back pain on average at least 3/10 pain intensity on a majority of days over the past 3 months
  3. report regular use of a prescription opioid medication for ≥3 months.

• Exclusion Criteria.
  1. significant medical or psychiatric morbidity within 6 months that would impair their ability to complete the study or lifetime history of bipolar disorder, psychotic disorder, schizophrenia
  2. Current alcohol or substance use disorder or receiving treatment for opioid use disorder
  3. Any behavior observed during participation that the investigators determine could compromise the integrity or safety of the study
  4. presence of any comorbid idiopathic or rheumatic chronic pain condition that is reported as the primary pain complaint.


Qualified Participants May Receive:

Baseline Session

$25

Ambulatory Monitoring Training Session

$25

Ambulatory Monitoring Data Burst 1

($5 per day X 14 days) + $100 bonus for ≥ 80% adherence = $170

Follow-up Session

$25

Ambulatory Monitoring Data Burst 2

$($5 per day X 14 days) + $100 bonus for ≥ 80% completion = $170

Study Completion Bonus

$100

TOTAL

Up to $515


If you or someone you care for is interested in participating and lives within 50 miles of the location shown, please complete the form below and click 'Submit'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.