Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT05050409

Conditions

Knee Pain Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brief mindfulness

Mindfulness-Oriented Recovery Enhancement (MORE)

Standard care

Study Details

Brief 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

Knee Pain Chronic

Study ID

NCT05050409

Start date

May 1, 2022

Status verified date

Mar, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Scheduled to undergo unilateral total TKA at one of the study sites
  • TRICARE beneficiary
  • Facility with the English language that is adequate to complete study procedures.

Exclusion Criteria:

  • Cognitive impairment preventing completion of study procedures,
  • Formal mindfulness training (e.g., MBSR, MBCT)
  • Severe, active suicidality
  • Contralateral TKA in the past 3 months or planned contralateral TKA during the study
  • Current cancer diagnoses.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brief mindfulness followed by brief mindfulness for non-responders

1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive another single session of brief mindfulness. Responders will continue to receive standard of care.

experimental: Standard care followed by brief mindfulness for non-responders

Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive one session of brief mindfulness. Responders will continue to receive standard of care.

experimental: Brief mindfulness followed by MORE for non-responders

1 session of brief mindfulness, plus standard of care. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.

experimental: Standard care followed by MORE for non-responders

Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. At the one-month post-surgical follow-up, non-responders will receive the 8 session MORE intervention. Responders will continue to receive standard of care.

Interventions

Brief mindfulness

A 15-minute guided mindfulness practice that includes focused attention on breath and body sensations and open monitoring and acceptance of thoughts, emotions, and pain.

Mindfulness-Oriented Recovery Enhancement (MORE)

An 8-session intervention. Sessions involve: 1) mindfulness training to reduce pain and increase self-regulation over opioid use, 2) cognitive reappraisal to decrease psychological distress, and 3) savoring to augment natural reward processing, positive emotion, and esprit de corps.

Standard care

Preoperative Standard Care. Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. Postoperative standard care includes (1) pain medications to minimize opioid use, including acetaminophen, lyrica, meloxicam/naproxen and celebrex, and (2) anticoagulants for 3-6 weeks postoperatively, as well as (3) ambulatory care with assistive devices 1-6 weeks after surgery. Patients see their surgeon postoperatively 2-6 weeks after surgery, 3-6 months, and yearly.

Primary outcome measure

  • Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index [ Time Frame: Baseline to 9 months ]

Central Contacts and Locations

Central contacts

Rachel Mayhew

253.968.2911rachel.j.mayhew.ctr@mail.mil

Tina Greenlee

tgreenlee@genevausa.org

Locations

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Tina Greenlee

Ttgreenlee@genevausa.org

More Information

Sponsor

University of Utah

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2025-03-27.