Status:
COMPLETED
Pain Response Evaluation of a Combined Intervention to Cope Effectively
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Chronic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 mus...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2024
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04395001
Start Date
February 24 2021
End Date
July 18 2024
Last Update
October 10 2025
Active Locations (1)
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1
Wake Forest Baptist Health Department of Rheumatology
Winston-Salem, North Carolina, United States, 27157