Phase 4 N=280 Randomized Single-blind Treatment

Pain Response Evaluation of a Combined Intervention to Cope Effectively

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT04395001 ↗

Enrolled (actual)

280

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Brief Pain Inventory (BPI) Total Pain Severity — 6.1; 5.7; 5.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: duloxetine (Drug); Web-based Cognitive Behavioral Therapy (CBT) (Behavioral); Nurse-delivered Motivational Interviewing (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Brief Pain Inventory (BPI) Total Pain Severity	3.7; 3.8; 3.8	—
PRIMARY Brief Pain Inventory (BPI) Total Pain Severity	3.7; 3.8; 3.8	—
PRIMARY Brief Pain Inventory (BPI)	3.5; 3.7; 3.6	—
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function	39.73; 40.2; 41.0	—
SECONDARY Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)	5.7; 6.6; 6.1	—
SECONDARY Generalized Anxiety Disorder 7-item Scale (GAD-7)	3.8; 3.7; 4.0	—

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).

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 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04395001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.