Pain Response Evaluation of a Combined Intervention to Cope Effectively

Phase 4

Completed

Interventions: Drug: duloxetine
Behavioral: Web-based Cognitive Behavioral Therapy (CBT)
Other: Nurse-delivered Motivational Interviewing

Brief Summary: The purpose of this research is is to determine if the combination of non-opioid medication (duloxetine) and web-based pain-coping skills training (PCST) is beneficial for individuals with chronic musculoskeletal pain (CMP).

Detailed Description: With this study, the study team hopes to address two important unanswered questions: (1) Does combination treatment consisting of duloxetine and web-based Cognitive Behavioral Therapy (CBT) optimize treatment outcomes? (2) Would adherence-focused guidance delivered by nurse clinician using motivational interviewing (MI) techniques enhance treatment effectiveness? This study is significant because the study team aims to optimize pain-related treatment outcomes at the primary care level where most patients with pain are managed. Importantly, the use of nurse clinician providing adherence-focused guidance (as opposed to content-focused guidance) on the continued practice (or use) of pain coping skills increases the likelihood that the study's intervention is scalable in the future. Effective, accessible and scalable psychoeducational treatments are needed to manage CMP in real world clinic settings.

Recruitment & Eligibility

Inclusion Criteria

patients at the primary care clinic with daily pain for 3 months or longer affecting the low back, neck, hip, knee or widespread pain;
at least moderate in BPI global pain severity

Exclusion Criteria

uncontrolled hypertension (because duloxetine rarely increases blood pressure)
active suicidal ideation
planned elective surgery during the study period (to avoid the confounding effect of possible complicated post-surgery recovery course on the primary outcome)
ongoing unresolved disability claims
inflammatory arthritis (e.g., lupus and ankylosing spondylitis)
cancer-related musculoskeletal pain
pregnancy
history of bipolar disorder or schizophrenia
narrow angle glaucoma
severe renal impairment (creatinine clearance <30)
current use of duloxetine
current use of any of the following medications (to avoid adverse drug-to-drug interactions): tricyclic antidepressant > 25 mg daily dose, monoamine oxidase inhibitors, fluoxetine, sertraline, paroxetine, citalopram, escitalopram, venlafaxine, milnacipran, mirtazapine, gabapentin or aripiprazole, serotonin precursors (e.g., tryptophan), and strong CYP1A2 inhibitors (e.g., ciprofloxacin, other fluoroquinolones, fluvoxamine and verapamil)

Arm && Interventions

Group	Intervention	Description
behavioral intervention, nurse support plus medication	Web-based Cognitive Behavioral Therapy (CBT)	Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
behavioral intervention, nurse support plus medication	duloxetine	Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
behavioral intervention, nurse support plus medication	Nurse-delivered Motivational Interviewing	Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
behavioral intervention plus medication	Web-based Cognitive Behavioral Therapy (CBT)	Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
behavioral intervention plus medication	duloxetine	Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
medication only	duloxetine	Subjects randomized to this arm will receive duloxetine only.

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory (BPI)	week 25 of treatment phase	BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Brief Pain Inventory (BPI) Total Pain Severity	week 13 of treatment phase	BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function	week 25 of treatment phase	Adult Self-Reported Measures on physical function. The values of the response to each physical function question will be summed in order to determine the raw score. This must then be converted to the T-score. T-scores are standardized with a mean of 50 and a standard deviation of 10. I.e. a T-score of 40 would be one standard deviation lower than the mean. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function a T-score of 60 is one standard deviation better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)	week 25 of treatment phase	Score is the sum of the 8 items. Score ranges from 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Generalized Anxiety Disorder 7-item Scale (GAD-7)	week 25 of treatment phase	Score ranges from 0-24. Scores of 5, 10, and 15 are the respective cut-offs for mild, moderate, and severe anxiety. Further evaluation is recommended when a score of 10 or greater is recorded.