Pain Response Evaluation of a Combined Intervention to Cope Effectively
CompletedPhase 4NCT04395001
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)
- Conditions
- Interventions
- Drug: duloxetine
- Behavioral: Web-based Cognitive Behavioral Therapy (CBT)
- Other: Nurse-delivered Motivational Interviewing
- Sponsor
- Wake Forest University Health Sciences
- Collaborators
- National Institute of Nursing Research (NINR)
- Start date
- 2021-02-24
- Primary completion
- 2024-07-18
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04395001