Clinical trial NCT03548454: Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
Official title: Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. Our work aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). Collaborative Health Outcomes Information Registry uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. The investigators will also compare adherence of patients to these two commonly used medications over a period of six months. This will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. Collaborative Health Outcomes Information Registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine.


Eligibility criteria: Inclusion criteria:

1. Age of 18 years old or above
2. Persistent pain for more than 3 months
3. Candidate for treatment by anti-depressant based on treating pain provider

Exclusion criteria:

1. Prior failure of duloxetine and/or desipramine (patients who have failed other TCAs or SNRIs can be considered for the trial based on the reason for previous medication failure)
2. Contraindication to taking duloxetine or desipramine
3. Patient refusal

Primary outcomes:
measure: Pain Intensity
timeFrame: Monthly for 6 months
Secondary outcomes:
measure: Physical Function
timeFrame: Monthly for 6 months
measure: Pain Interference
timeFrame: Monthly for 6 months
measure: Depression
timeFrame: Monthly for 6 months
measure: Anxiety
timeFrame: Monthly for 6 months
measure: Adherence
timeFrame: Monthly for 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Pain Management Center
state: California
Study officials:
affiliation: Stanford University
name: Vafi Salmasi, MD.
role: PRINCIPAL_INVESTIGATOR
References: