Pain Response Evaluation of a Combined Intervention to Cope Effectively

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2024-07-18

Brief Summary

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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).

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Detailed Description

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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

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The project manager, who is blinded of treatment group assignment, has the primary responsibility of collecting outcome data throughout the study.

Study Groups

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behavioral intervention, nurse support plus medication

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

Group Type EXPERIMENTAL

duloxetine

Intervention Type DRUG

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)

Intervention Type 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.

Nurse-delivered Motivational Interviewing

Intervention Type 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 plus medication

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

Group Type EXPERIMENTAL

duloxetine

Intervention Type DRUG

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)

Intervention Type 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.

medication only

Subjects randomized to this arm will receive duloxetine only.

Group Type ACTIVE_COMPARATOR

duloxetine

Intervention Type DRUG

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

Interventions

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duloxetine

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

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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Irenka Cymbalta

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No