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

September 29, 2025 updated by: Wake Forest University Health Sciences

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 treatment outcomes? (2) Would adherence-focused guidance delivered by nurse clinician using motivational interviewing (MI) techniques enhance treatment effectiveness? This study is significant because the study team aims to optimize pain-related treatment outcomes at the primary care level where most patients with pain are managed. Importantly, the use of nurse clinician providing adherence-focused guidance (as opposed to content-focused guidance) on the continued practice (or use) of pain coping skills increases the likelihood that the study's intervention is scalable in the future. Effective, accessible and scalable psychoeducational treatments are needed to manage CMP in real world clinic settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Department of Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: behavioral intervention, nurse support plus medication
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
Drug: duloxetine
All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Other Names:
  • Cymbalta
  • Irenka
Behavioral: 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.
Other: 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.
Experimental: behavioral intervention plus medication
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
Drug: duloxetine
All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Other Names:
  • Cymbalta
  • Irenka
Behavioral: 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.
Active Comparator: medication only
Subjects randomized to this arm will receive duloxetine only.
Drug: duloxetine
All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Other Names:
  • Cymbalta
  • Irenka

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: week 25 of treatment phase
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
week 25 of treatment phase
Brief Pain Inventory (BPI) Total Pain Severity
Time Frame: Baseline
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Baseline
Brief Pain Inventory (BPI) Total Pain Severity
Time Frame: week 13 of treatment phase
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
week 13 of treatment phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Time Frame: week 25 of treatment phase
Adult Self-Reported Measures on physical function. The values of the response to each physical function question will be summed in order to determine the raw score. This must then be converted to the T-score. T-scores are standardized with a mean of 50 and a standard deviation of 10. I.e. a T-score of 40 would be one standard deviation lower than the mean. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function a T-score of 60 is one standard deviation better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
week 25 of treatment phase
Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)
Time Frame: week 25 of treatment phase
Score is the sum of the 8 items. Score ranges from 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
week 25 of treatment phase
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time Frame: week 25 of treatment phase
Score ranges from 0-24. Scores of 5, 10, and 15 are the respective cut-offs for mild, moderate, and severe anxiety. Further evaluation is recommended when a score of 10 or greater is recorded.
week 25 of treatment phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dennis C Ang, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00065428
  • 1UG3NR019196-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Protecting the rights and privacy of our study participants is our first priority. After Internal Review Board approval for data sharing is obtained, a dataset that is de-identified and in accordance with HIPAA and other state and federal right to privacy laws will be developed by the investigators. Data obtained during the study will be made available beginning after publication of the main findings of the study. Notification of availability of de-identified data will be made in the acknowledgement section of all subsequent publications resulting from the study. Data will be provided in standard SAS format. Investigators interested in obtaining de-identified study data will be instructed to send a blank compact disc to the primary investigator for copying.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

For individual participant data, meta-analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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