Pain Response Evaluation of a Combined Intervention to Cope Effectively

NCT04395001 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB000654281UG3NR019196-01
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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 musculoskeletal pain (CMP).

Conditions

Chronic Pain

Keywords

non-opioid pain medication; psychoeducational treatments; chronic musculoskeletal pain

Outcome Measures

Primary Outcomes (3)

• Brief Pain Inventory (BPI) Total Pain Severity

  BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.

  Baseline

• Brief Pain Inventory (BPI) Total Pain Severity

  BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.

  week 13 of treatment phase

• Brief Pain Inventory (BPI)

  BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.

  week 25 of treatment phase

Secondary Outcomes (3)

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function

  week 25 of treatment phase

• Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)

  week 25 of treatment phase

• Generalized Anxiety Disorder 7-item Scale (GAD-7)

  week 25 of treatment phase

Study Arms (3)

behavioral intervention, nurse support plus medication

EXPERIMENTAL

Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.

Drug: duloxetine; Behavioral: Web-based Cognitive Behavioral Therapy (CBT); Other: Nurse-delivered Motivational Interviewing

behavioral intervention plus medication

EXPERIMENTAL

Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).

Drug: duloxetine; Behavioral: Web-based Cognitive Behavioral Therapy (CBT)

medication only

ACTIVE COMPARATOR

Subjects randomized to this arm will receive duloxetine only.

Drug: duloxetine

Interventions

duloxetine DRUG

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

Also known as: Irenka, Cymbalta

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

Web-based Cognitive Behavioral Therapy (CBT) BEHAVIORAL

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.

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

Nurse-delivered Motivational Interviewing OTHER

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.

behavioral intervention, nurse support plus medication

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Wake Forest Baptist Health Department of Rheumatology

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• Ang DC, Davuluri S, Kaplan S, Keefe F, Rini C, Miles C, Chen H. Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial. Trials. 2024 May 18;25(1):330. doi: 10.1186/s13063-024-08158-x.

  PMID: 38762720 DERIVED

• Ang DC, Davuluri S, Kaplan S, Keefe F, Rini C, Miles C, Chen H. Duloxetine and Cognitive Behavioral Therapy with Phone-based Support for the Treatment of Chronic Musculoskeletal Pain: Study Protocol of the PRECICE Randomized Control Trial. Res Sq [Preprint]. 2024 Apr 15:rs.3.rs-3924330. doi: 10.21203/rs.3.rs-3924330/v1.

  PMID: 38699346 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dennis C. Ang
• Organization: Wake Forest School of Medicine

dang@wakehealth.edu

3367058701

Study Officials

• Dennis C Ang, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The project manager, who is blinded of treatment group assignment, has the primary responsibility of collecting outcome data throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: February 24, 2021
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: October 10, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication. No end date.
• Access Criteria: For individual participant data, meta-analysis

Locations

US (1)