Back to resultsPain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
duloxetine
Web-based Cognitive Behavioral Therapy (CBT)
Nurse-delivered Motivational Interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring non-opioid pain medication, psychoeducational treatments, chronic musculoskeletal pain
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)
Sites / Locations
- Wake Forest Baptist Health Department of RheumatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
behavioral intervention, nurse support plus medication
behavioral intervention plus medication
medication only
Arm Description
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
Subjects randomized to this arm will receive duloxetine only.
Outcomes
Primary Outcome Measures
Brief Pain Inventory (BPI)
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Brief Pain Inventory (BPI)
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Brief Pain Inventory (BPI)
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Secondary Outcome Measures
Patient-Reported Outcomes Measurement Information System (PROMIS)
Adult Self-Reported Measures on physical health (fatigue, pain intensity, pain interference, physical function, sleep disturbance, pain behavior and sleep-related impairment) and social health (ability to participate in social roles and activities). The values of the response to each 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.
The Pain Catastrophizing Scale (PCS)
13-item scale that describes the catastrophic thoughts and feelings that people may have in response to pain. The total score ranges 0 (no catastrophizing) to 52 (severe catastrophizing).
Global Rating of Change
Score ranges from -5 through 5 with 5 denoting a better outcome; 0 denotes no change
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.
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.
Patient Health Quality Anxiety-Depression Scale (PHQ-ADS)
PHQ-ADS is a single measure for assessing psychological distress in clinical practice and research. Scores range from 0-30. PHQ-ADS cut points of 10, 20 and 30 were shown to represent mild, moderate, and severe levels of psychological distress, respectively.
Frequency of Practicing Pain Coping Skills
Study team will ask participants how many days they practiced pain coping skills in the past 2 weeks (maximum of 14)
Opioid Morphine Equivalent (OME)
The study will use self-reported opioid type, medical record-based dosage and self-reported daily frequency to calculate the OME, reported in milligrams per day. The OME is calculated by multiplying dosage by daily frequency by a conversion factor for each opioid based on opioid strength.
relevant concomitant medication use--non-steroidal anti-inflammatory drugs (NSAIDS)
Number of subjects who use NSAIDS between visits will be collected
relevant concomitant medication use--muscle relaxants
Number of subjects who use muscle relaxants between visits will be collected
Number of Subjects who use Physical Therapy between visits
Number of Subjects who use occupational therapy between visits
Number of Subjects who use acupuncture between visits
Number of Subjects who use massage between visits
Number of Subjects who go to a chiropractor between visits
Number of Subjects who go to a pain specialist between visits
Number of Subjects who use pain psychologist between visits
Full Information
NCT ID
NCT04395001
First Posted
May 15, 2020
Last Updated
March 27, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04395001
Brief Title
Pain Response Evaluation of a Combined Intervention to Cope Effectively
Acronym
PRECICE
Official Title
Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
non-opioid pain medication, psychoeducational treatments, chronic musculoskeletal pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The project manager, who is blinded of treatment group assignment, has the primary responsibility of collecting outcome data throughout the study.
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
behavioral intervention, nurse support plus medication
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support.
Arm Title
behavioral intervention plus medication
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT).
Arm Title
medication only
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive duloxetine only.
Intervention Type
Drug
Intervention Name(s)
duloxetine
Other Intervention Name(s)
Irenka, Cymbalta
Intervention Description
All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Web-based Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nurse-delivered Motivational Interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Pain Inventory (BPI)
Description
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Time Frame
Baseline
Title
Brief Pain Inventory (BPI)
Description
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Time Frame
week 13 of treatment phase
Title
Brief Pain Inventory (BPI)
Description
BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.
Time Frame
week 25 of treatment phase
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)
Description
Adult Self-Reported Measures on physical health (fatigue, pain intensity, pain interference, physical function, sleep disturbance, pain behavior and sleep-related impairment) and social health (ability to participate in social roles and activities). The values of the response to each 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.
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
The Pain Catastrophizing Scale (PCS)
Description
13-item scale that describes the catastrophic thoughts and feelings that people may have in response to pain. The total score ranges 0 (no catastrophizing) to 52 (severe catastrophizing).
Time Frame
Baseline, week 13 of treatment phase, week 25 of treatment phase
Title
Global Rating of Change
Description
Score ranges from -5 through 5 with 5 denoting a better outcome; 0 denotes no change
Time Frame
Baseline, week 13 of treatment phase, week 25 of treatment phase
Title
Patient Health Questionnaire 8-Item Depression Scale (PHQ-8)
Description
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.
Time Frame
Baseline, week 13 of treatment phase, week 25 of treatment phase
Title
Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
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.
Time Frame
Baseline, week 13 of treatment phase, week 25 of treatment phase
Title
Patient Health Quality Anxiety-Depression Scale (PHQ-ADS)
Description
PHQ-ADS is a single measure for assessing psychological distress in clinical practice and research. Scores range from 0-30. PHQ-ADS cut points of 10, 20 and 30 were shown to represent mild, moderate, and severe levels of psychological distress, respectively.
Time Frame
Baseline, week 13 of treatment phase, week 25 of treatment phase
Title
Frequency of Practicing Pain Coping Skills
Description
Study team will ask participants how many days they practiced pain coping skills in the past 2 weeks (maximum of 14)
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Opioid Morphine Equivalent (OME)
Description
The study will use self-reported opioid type, medical record-based dosage and self-reported daily frequency to calculate the OME, reported in milligrams per day. The OME is calculated by multiplying dosage by daily frequency by a conversion factor for each opioid based on opioid strength.
Time Frame
Baseline, week 13 of treatment phase, week 25 of treatment phase
Title
relevant concomitant medication use--non-steroidal anti-inflammatory drugs (NSAIDS)
Description
Number of subjects who use NSAIDS between visits will be collected
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
relevant concomitant medication use--muscle relaxants
Description
Number of subjects who use muscle relaxants between visits will be collected
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Number of Subjects who use Physical Therapy between visits
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Number of Subjects who use occupational therapy between visits
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Number of Subjects who use acupuncture between visits
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Number of Subjects who use massage between visits
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Number of Subjects who go to a chiropractor between visits
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Number of Subjects who go to a pain specialist between visits
Time Frame
week 13 of treatment phase, week 25 of treatment phase
Title
Number of Subjects who use pain psychologist between visits
Time Frame
week 13 of treatment phase, week 25 of treatment phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judy Hooker
Phone
336-716-0186
Email
jhooker@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis C Ang, MD
Phone
336-713-4504
Email
dang@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis C Ang, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health Department of Rheumatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Hooker
Phone
336-716-0186
Email
jhooker@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Dennis C Ang, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Pain Response Evaluation of a Combined Intervention to Cope Effectively
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