Chronic Pain
Conditions
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.
Interventions
DRUGDuloxetine
Open label prescription
DRUGDesipramine
Open label prescription
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Desipramine Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated. | 38 |
| Duloxetine Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated. | 48 |
| Total | 86 |
Baseline characteristics
| Characteristic | Duloxetine | Total | Desipramine |
|---|---|---|---|
| Age, Continuous | 47.25 years STANDARD_DEVIATION 16.67 | 47.48 years STANDARD_DEVIATION 15.62 | 47.78 years STANDARD_DEVIATION 14.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 15 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 60 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 11 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 20 Participants | 10 Participants |
| Race/Ethnicity, Customized Unknown/Refused | 9 Participants | 11 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 44 Participants | 18 Participants |
| Region of Enrollment United States | 48 Participants | 86 Participants | 38 Participants |
| Sex: Female, Male Female | 29 Participants | 47 Participants | 18 Participants |
| Sex: Female, Male Male | 19 Participants | 39 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 48 |
| other Total, other adverse events | 6 / 38 | 4 / 48 |
| serious Total, serious adverse events | 0 / 38 | 0 / 48 |
Outcome results
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).
Time frame: baseline and 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Desipramine | Pain Intensity | 11 Participants |
| Duloxetine | Pain Intensity | 29 Participants |
Secondary
Adherence
Number of participants who completed 6-month therapy based on prescription records.
Time frame: Monthly for 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Desipramine | Adherence | 18 Participants |
| Duloxetine | Adherence | 24 Participants |
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.
Time frame: Baseline and 6 months
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desipramine | Anxiety | Baseline | 54.39 T-score | Standard Deviation 10.21 |
| Desipramine | Anxiety | 6-month | 54.97 T-score | Standard Deviation 9.65 |
| Desipramine | Anxiety | Change from baseline at 6-month | -1.2 T-score | Standard Deviation 7.11 |
| Duloxetine | Anxiety | Baseline | 54.65 T-score | Standard Deviation 8.99 |
| Duloxetine | Anxiety | 6-month | 54.01 T-score | Standard Deviation 11.72 |
| Duloxetine | Anxiety | Change from baseline at 6-month | -1.29 T-score | Standard Deviation 11.89 |
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.
Time frame: Baseline and 6 months
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desipramine | Depression | Baseline | 52.98 T-score | Standard Deviation 9.4 |
| Desipramine | Depression | 6-month | 52.54 T-score | Standard Deviation 9.7 |
| Desipramine | Depression | Change from baseline at 6-month | -3.24 T-score | Standard Deviation 6.58 |
| Duloxetine | Depression | Baseline | 54.24 T-score | Standard Deviation 8.89 |
| Duloxetine | Depression | 6-month | 53.39 T-score | Standard Deviation 11.93 |
| Duloxetine | Depression | Change from baseline at 6-month | -1.14 T-score | Standard Deviation 12.83 |
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.
Time frame: Baseline and 6 months
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desipramine | Pain Interference | Baseline | 64.37 T-score | Standard Deviation 7.1 |
| Desipramine | Pain Interference | 6-month | 60.82 T-score | Standard Deviation 7.1 |
| Desipramine | Pain Interference | Change from baseline at 6-month | -4.29 T-score | Standard Deviation 7.57 |
| Duloxetine | Pain Interference | Baseline | 64.93 T-score | Standard Deviation 6.48 |
| Duloxetine | Pain Interference | 6-month | 62.11 T-score | Standard Deviation 6.98 |
| Duloxetine | Pain Interference | Change from baseline at 6-month | -4.06 T-score | Standard Deviation 7.51 |
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.
Time frame: Baseline and 6 months
Population: Participants with data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Desipramine | Physical Function | Baseline | 39.29 T-score | Standard Deviation 7.63 |
| Desipramine | Physical Function | 6-month | 41.9 T-score | Standard Deviation 8.91 |
| Desipramine | Physical Function | Change from baseline at 6-month | 2.54 T-score | Standard Deviation 5.83 |
| Duloxetine | Physical Function | Baseline | 39.07 T-score | Standard Deviation 6.33 |
| Duloxetine | Physical Function | 6-month | 39.39 T-score | Standard Deviation 6.98 |
| Duloxetine | Physical Function | Change from baseline at 6-month | 1.36 T-score | Standard Deviation 3.88 |