Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Chronic Pain

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04395001

1UG3NR019196-01 (U.S. NIH Grant/Contract)

IRB00065428

Details and patient eligibility

About

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).

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 3 patient groups

behavioral intervention, nurse support plus medication

Experimental group

Description:

Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.

Treatment:

Behavioral: Web-based Cognitive Behavioral Therapy (CBT)

Drug: duloxetine

Other: Nurse-delivered Motivational Interviewing

behavioral intervention plus medication

Experimental group

Description:

Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).

Treatment:

Behavioral: Web-based Cognitive Behavioral Therapy (CBT)

Drug: duloxetine

medication only

Active Comparator group

Description:

Subjects randomized to this arm will receive duloxetine only.

Treatment:

Drug: duloxetine