Pain Response Evaluation of a Combined Intervention to Cope Effectively

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Duloxetine Hydrochloride

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)