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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. |
|
| Desipramine | Experimental | Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Open label prescription |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | 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). | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | 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. | Baseline and 6 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vafi Salmasi, MD. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Pain Management Center | Redwood City | California | 94063 | United States |
Patients were equally randomized to duloxetine and desipramine (43 in each arm); however, five patients chose not to take desipramine and crossed over to the duloxetine group before starting study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Desipramine | Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. |
| FG001 | Duloxetine | Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Desipramine | Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. |
| BG001 | Duloxetine | Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Intensity | 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). | Posted | Count of Participants | Participants | baseline and 6 months |
|
During 6 months duration of the study
All participants were systematically inquired about presence of adverse events during each study survey
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Desipramine | Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Did not tolerate | Investigations | Systematic Assessment | Patient mentioned they did not tolerate the medication and refused to provide more information why |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vafi Salmasi | Stanford University | 650-725-0246 | vsalmasi@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2022 | Oct 22, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Original Statistical Analysis Plan | Apr 24, 2018 | Oct 22, 2025 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Revised Statistical Analysis Plan | Mar 28, 2025 | Oct 22, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| D003891 | Desipramine |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Desipramine | Drug | Open label prescription |
|
|
| Pain Interference | 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. | Baseline and 6 months |
| Depression | 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. | Baseline and 6 months |
| Anxiety | 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. | Baseline and 6 months |
| Adherence | Number of participants who completed 6-month therapy based on prescription records. | Monthly for 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Participants with non-missing data | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Physical Function | 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. | Participants with data at the respective time point | Posted | Mean | Standard Deviation | T-score | Baseline and 6 months |
|
|
|
| Secondary | Pain Interference | 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. | Participants with data at the respective time point | Posted | Mean | Standard Deviation | T-score | Baseline and 6 months |
|
|
|
| Secondary | Depression | 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. | Participants with data at the respective time point | Posted | Mean | Standard Deviation | T-score | Baseline and 6 months |
|
|
|
| Secondary | Anxiety | 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. | Participants with data at the respective time point | Posted | Mean | Standard Deviation | T-score | Baseline and 6 months |
|
|
|
| Secondary | Adherence | Number of participants who completed 6-month therapy based on prescription records. | Posted | Count of Participants | Participants | Monthly for 6 months |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 6 |
| 38 |
| EG001 | Duloxetine | Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. | 0 | 48 | 0 | 48 | 4 | 48 |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Drowsiness | Nervous system disorders | Systematic Assessment | Daytime drowsiness |
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| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment | prolonged bleeding and easier bruising |
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| Urinary frequency | Renal and urinary disorders | Systematic Assessment | urinary frequency and urgency |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Increased pain | Nervous system disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 6-month |
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| Change from baseline at 6-month |
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| 6-month |
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| Change from baseline at 6-month |
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| 6-month |
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| Change from baseline at 6-month |
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| 6-month |
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| Change from baseline at 6-month |
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