Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Desipramine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age of 18 years old or above Persistent pain for more than 3 months Candidate for treatment by anti-depressant based on treating pain provider Exclusion criteria: 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) Contraindication to taking duloxetine or desipramine Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br>Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. | Drug: Duloxetine<br>* Open label prescription<br>* Other names: Cymbalta;|
| Experimental: Desipramine<br>Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. | Drug: Desipramine<br>* Open label prescription<br>* Other names: Norpramin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Average and worst pain intensity reported by participants on a numerical rating scale of 0-10 | Monthly for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Function | National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function | Monthly for 6 months | 
| Pain Interference | National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference | Monthly for 6 months | 
| Depression | National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression | Monthly for 6 months | 
| Anxiety | National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety | Monthly for 6 months | 
| Adherence | Time to stopping either medication in days | Monthly for 6 months |