Phase 4
Completed N=280
Pain Response Evaluation of a Combined Intervention to Cope Effectively
Source: ClinicalTrials.gov NCT04395001 ↗Enrolled (actual)
280
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Brief Pain Inventory (BPI) Total Pain Severity — 6.1; 5.7; 5.8 score on a scale
◆ Published Evidence
Emerging
2citations · ~1 / year
Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial.
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).
Linked Publications (2)
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Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial.
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Duloxetine and Cognitive Behavioral Therapy with Phone-based Support for the Treatment of Chronic Musculoskeletal Pain: Study Protocol of the PRECICE Randomized Control Trial.
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) |
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 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04395001) and the linked publication. 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. Informational only — not medical advice.