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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2024
  • participants needed
    280
  • sponsor
    Wake Forest University Health Sciences
Updated on 25 April 2022
opioid
behavior therapy
duloxetine

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).

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.

Details
Condition Chronic Pain
Treatment Duloxetine, Web-based Cognitive Behavioral Therapy (CBT), Nurse-delivered Motivational Interviewing
Clinical Study IdentifierNCT04395001
SponsorWake Forest University Health Sciences
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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