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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: Recruiting NA study of Knee Pain Chronic, sponsored by University of Utah.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2027-10 |
| Phase | NA |
What NCT05050409 shows while recruiting
NCT05050409 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 215-participant average among 18 other Knee Pain Chronic trials with a reported enrollment target (133% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Knee Pain Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05050409's enrollment target sits among peer trials
500 3rd of 18 higher than 16 of 18 other Knee Pain Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Knee Pain Chronic 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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