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NCT04395001 · ClinicalTrials.gov registry record · Phase 4

Pain Response Evaluation of a Combined Intervention to Cope Effectively

A Phase 4 study, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 4
Development phase
280
Enrollment target

NCT04395001: Completed Phase 4 study, sponsored by Wake Forest University Health Sciences.

NCT04395001 is a Phase 4 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 280 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04395001, a Phase 4 study, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 4
Development phase
280 participants
Enrollment target

Study 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).

Primary Outcome

BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity.

Interventions

  • DRUG duloxetine
  • BEHAVIORAL Web-based Cognitive Behavioral Therapy (CBT)
  • OTHER Nurse-delivered Motivational Interviewing

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2021-02-24
Est. Completion 2024-07-18
Phase Phase 4
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT04395001 record still lists

NCT04395001 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower).

The record links to 0 conditions, and to 3 interventions - of which duloxetine is the first listed.

NCT04395001 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04395001 about?

NCT04395001 is a clinical study titled "Pain Response Evaluation of a Combined Intervention to Cope Effectively". 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).

What is the current status of trial NCT04395001?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 280 participants. The study started on 2021-02-24. Estimated completion is 2024-07-18.

What interventions are being tested in trial NCT04395001?

The interventions under investigation include: duloxetine (DRUG), Web-based Cognitive Behavioral Therapy (CBT) (BEHAVIORAL), Nurse-delivered Motivational Interviewing (OTHER).

Who is sponsoring clinical trial NCT04395001?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04395001's enrollment target sits among peer trials

280 303rd of 2000 higher than 1,696 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04395001, the US trial registry maintained by the National Library of Medicine. NCT04395001 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.