Chronic PainPhase 4PRECICENCT04395001
Pain Response Evaluation of a Combined Intervention to Cope Effectively
A Phase 4 study testing duloxetine, Web-based Cognitive Behavioral Therapy (CBT) and Nurse-delivered Motivational Interviewing in people with Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- duloxetine, Web-based Cognitive Behavioral Therapy (CBT) and Nurse-delivered Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 18 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health Department of Rheumatology
Winston-Salem, North Carolina, 27157
About this study
Official title: 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).
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- duloxetine, Web-based Cognitive Behavioral Therapy (CBT), Nurse-delivered Motivational Interviewing
- Keywords
- non-opioid pain medication, psychoeducational treatments, chronic musculoskeletal pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called Irenka, Cymbalta
All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Web-based Cognitive Behavioral Therapy (CBT)Behavioural
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.
Nurse-delivered Motivational InterviewingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| behavioral intervention, nurse support plus medication | Experimental | Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support. Receives: 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). Receives: Drug: duloxetine; Behavioral: Web-based Cognitive Behavioral Therapy (CBT) |
| medication only | Active comparator | Subjects randomized to this arm will receive duloxetine only. Receives: Drug: duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory (BPI) Total Pain Severity
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Measured: Baseline
Brief Pain Inventory (BPI) Total Pain Severity
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Measured: 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.
Measured: week 25 of treatment phase
Secondary outcomes (3)
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
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.
Measured: week 25 of treatment phase
Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)
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.
Measured: week 25 of treatment phase
Generalized Anxiety Disorder 7-item Scale (GAD-7)
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.
Measured: week 25 of treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start24 Feb 2021
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Dennis C Ang, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395001
- Sponsor's protocol ID
- IRB00065428
- Other IDs
- 1UG3NR019196-01
- Acronym
- PRECICE
- Status last verified
- Sep 2025
- First submitted
- 15 May 2020
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38762720Ang 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.
PubMed 38699346
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)
- ClinicalTrials.gov ID
- NCT04395001
- Acronym / sponsor ID
- PRECICE / IRB00065428
- Conditions
- Chronic Pain
- Keywords
- non-opioid pain medication, psychoeducational treatments, chronic musculoskeletal pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| behavioral intervention, nurse support plus medication | Experimental | Drug: duloxetine, Behavioral: Web-based Cognitive Behavioral Therapy (CBT), Other: Nurse-delivered Motivational InterviewingSubjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support. |
| behavioral intervention plus medication | Experimental | Drug: duloxetine, Behavioral: Web-based Cognitive Behavioral Therapy (CBT)Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT). |
| medication only | Active comparator | Drug: duloxetineSubjects randomized to this arm will receive duloxetine only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duloxetineAlso: Irenka, CymbaltaAll participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. | Drug | behavioral intervention plus medication, behavioral intervention, nurse support plus medication, medication only |
| 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. | Behavioural | behavioral intervention plus medication, behavioral intervention, nurse support plus medication |
| Nurse-delivered Motivational InterviewingSubjects 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. | Other | behavioral intervention, nurse support plus medication |
Primary outcome
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.
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.
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.
3 secondary outcomes
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Time frame: week 25 of treatment phase
Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)
Time frame: week 25 of treatment phase
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: week 25 of treatment phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38762720Ang 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.
- Derived from this study: PubMed 38699346Ang 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis C Ang, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing duloxetine, Web-based Cognitive Behavioral Therapy (CBT) and Nurse-delivered Motivational Interviewing in people with Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) Total Pain Severity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04395001, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.