Clinical trial NCT04395001: Pain Response Evaluation of a Combined Intervention to Cope Effectively
Official title: Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: non-opioid pain medication
psychoeducational treatments
chronic musculoskeletal pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-05-20
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brief Pain Inventory (BPI) Total Pain Severity
timeFrame: Baseline
measure: Brief Pain Inventory (BPI) Total Pain Severity
timeFrame: week 13 of treatment phase
measure: Brief Pain Inventory (BPI)
timeFrame: week 25 of treatment phase
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
timeFrame: week 25 of treatment phase
measure: Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)
timeFrame: week 25 of treatment phase
measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: week 25 of treatment phase
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Department of Rheumatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Dennis C Ang, MD
role: PRINCIPAL_INVESTIGATOR
References: