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NCT05050409 · ClinicalTrials.gov registry record · NA

SMART Embedded Intervention for Military Postsurgical Engagement Readiness

A NA study of Knee Pain Chronic, sponsored by University of Utah.

Recruiting
Registry status
NA
Development phase
500
Enrollment target
1
Study location

NCT05050409 is a NA study of Knee Pain Chronic that is actively recruiting participants, run by University of Utah. The registered enrollment target is 500 participants, above the 215-participant average among 18 other Knee Pain Chronic trials with a reported enrollment target (133% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05050409, a NA study of Knee Pain Chronic, is actively recruiting participants, sponsored by University of Utah.

RECRUITING
Registry status
NA
Development phase
500 participants
Enrollment target
1
Study location

Study Summary

The overarching objective of this proposal is to conduct a multi-site Sequential Multiple Assignment Randomized Trial (SMART) across multiple Military Health System (MHS) sites to optimize the sequencing and integration of two intervention strategies in total knee arthoplasty (TKA) patients: a single-session mindfulness-based intervention (MBI) and an intensive 8-week MBI-Mindfulness-Oriented Recovery Enhancement (MORE) designed to simultaneously reduce prolonged pain and chronic opioid use by enhancing self-regulation. Aim 1: Evaluate the extent to which a brief preoperative MBI improves TKA patients' postoperative musculoskeletal health and reduces chronic opioid use. Aim 2: Evaluate the extent to which an intensive MBI (MORE) improves musculoskeletal health and reduces chronic opioid use among patients non-responsive to preoperative intervention. Aim 3: (A) Determine patient baseline characteristics that moderate MBI treatment responses. (B) Quantify the degree to which the impact of Phase 1 and 2 MBIs on musculoskeletal health and opioid dose are mediated by changes in mechanistic autonomic marker of self-regulation: heart-rate variability (HRV).

Conditions Studied

Knee Pain Chronic

Interventions

  • OTHER Standard care
  • BEHAVIORAL Mindfulness-Oriented Recovery Enhancement (MORE)
  • BEHAVIORAL Brief mindfulness

Study Locations (1)

Texas

  • Brooke Army Medical Center - Fort Sam Houston

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2022-05-01
Est. Completion 2027-10
Phase NA

Sponsor

University of Utah

818 total trials

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What the Registry Record Tells You About NCT05050409

The ClinicalTrials.gov registry entry for NCT05050409 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 215-participant average among 18 other Knee Pain Chronic trials with a reported enrollment target (133% higher). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Knee Pain Chronic appearing as the primary indexed condition, and to 3 interventions - of which Standard care is the first listed.

NCT05050409 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT05050409 about?

NCT05050409 is a clinical study titled "SMART Embedded Intervention for Military Postsurgical Engagement Readiness". The overarching objective of this proposal is to conduct a multi-site Sequential Multiple Assignment Randomized Trial (SMART) across multiple Military Health System (MHS) sites to optimize the sequencing and integration of two intervention strategies in total knee arthoplasty (TKA) patients: a singl...

What is the current status of trial NCT05050409?

This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2022-05-01. Estimated completion is 2027-10.

What conditions does trial NCT05050409 study?

This clinical trial studies the following conditions: Knee Pain Chronic.

What interventions are being tested in trial NCT05050409?

The interventions under investigation include: Standard care (OTHER), Mindfulness-Oriented Recovery Enhancement (MORE) (BEHAVIORAL), Brief mindfulness (BEHAVIORAL).

Who is sponsoring clinical trial NCT05050409?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05050409 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.