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

Phase 4

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Duloxetine; Drug: Desipramine

• Registration Number: NCT03548454
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-06-07
• Study Start: 2018-09-20
• Primary Completion: 2023-12-24
• Study Completion: 2024-06-26
• Results First Submitted: 2025-08-29
• Status Verified: 2025-10
• Results First Submitted QC: 2025-10-22
• Last Update Submitted: 2025-10-22
• Results First Posted: 2025-11-06
• Last Update Posted: 2025-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duloxetine	Duloxetine	Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.
Desipramine	Desipramine	Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	baseline and 6 months	Percent of participants in each arm that had more than 30% reduction in pain intensity. Participants rated their pain on an 11-point scale (0 to 10; 0 = no pain, 10 = worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Physical Function	Baseline and 6 months	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to better function.
Pain Interference	Baseline and 6 months	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to worse pain interference.
Depression	Baseline and 6 months	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to more severe depression.
Anxiety	Baseline and 6 months	National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to more severe anxiety.
Adherence	Monthly for 6 months	Number of participants who completed 6-month therapy based on prescription records.

Trial Locations

Locations (1)

Stanford Pain Management Center; 🇺🇸 Redwood City, California, United States