Clinical trial

Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)

Name

IRB00065428

Description

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).

Trial arms

Trial start

2021-02-24

Estimated PCD

2024-06-01

Trial end

2024-08-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

duloxetine

All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.

Arms:

behavioral intervention plus medication, behavioral intervention, nurse support plus medication, medication only

Other names:

Irenka, Cymbalta

Web-based Cognitive Behavioral Therapy (CBT)

The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.

Arms:

behavioral intervention plus medication, behavioral intervention, nurse support plus medication

Nurse-delivered Motivational Interviewing

Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.

Arms:

behavioral intervention, nurse support plus medication

Size

280

Primary endpoint

Brief Pain Inventory (BPI)

Baseline

Brief Pain Inventory (BPI)

week 13 of treatment phase

Brief Pain Inventory (BPI)

week 25 of treatment phase

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 \<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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The project manager, who is blinded of treatment group assignment, has the primary responsibility of collecting outcome data throughout the study.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

Updated at

2024-02-29

1 organization

1 drug

1 indication

Organization

Wake Forest University Health Sciences

Drug

duloxetine

Indication

Chronic Pain