Knee Pain ChronicSEMPERNCT05050409
SMART Embedded Intervention for Military Postsurgical Engagement Readiness
A study testing Brief mindfulness and Mindfulness-Oriented Recovery Enhancement (MORE) in people with Knee Pain Chronic, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Brief mindfulness and Mindfulness-Oriented Recovery Enhancement (MORE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tina Greenlee contact
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Tina Greenlee, Ttgreenlee@genevausa.org
About this study
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
- Being tested
- Brief mindfulness, Mindfulness-Oriented Recovery Enhancement (MORE), Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mindfulnessBehavioural
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)Behavioural
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief mindfulness followed by brief mindfulness for non-responders | Experimental | 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. Receives: Behavioral: Brief mindfulness |
| Standard care followed by brief mindfulness for non-responders | Experimental | 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. Receives: Behavioral: Brief mindfulness; Other: Standard care |
| Brief mindfulness followed by MORE for non-responders | Experimental | 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. Receives: Behavioral: Brief mindfulness; Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) |
| Standard care followed by MORE for non-responders | Experimental | 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. Receives: Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE); Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index
Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis).
Measured: Baseline to 9 months
Secondary outcomes (5)
Opioid use
Opioid use will be assessed by triangulating EHR data from the pharmacy data transaction service (PDTS) with real-time self-reports using a smartphone-enabled daily diary and retrospective reports with the validated Timeline Followback procedure.
Measured: Baseline to 9 months
Distress
Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress)
Measured: Baseline to 9 months
Defense and Veterans Pain Rating Scale
Defense and Veterans Pain Rating Scale, a numeric rating scale enhanced by word descriptors, color coding, and pictorial facial expressions matched to pain levels (0 to 10, higher scores indicating worse pain)
Measured: Baseline to 9 months
Opioid misuse
Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse)
Measured: Baseline to 9 months
Health-related quality of life
EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life)
Measured: Baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 May 2022
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- The Geneva Foundation
- Responsible party
- Principal investigator, Eric Garland, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050409
- Sponsor's protocol ID
- DOD02
- Acronym
- SEMPER
- Status last verified
- Mar 2025
- First submitted
- 9 Sep 2021
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Embedded Intervention for Military Postsurgical Engagement Readiness
- ClinicalTrials.gov ID
- NCT05050409
- Acronym / sponsor ID
- SEMPER / DOD02
- Conditions
- Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- The Geneva Foundation
- Study start
- 1 May 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
| Arm | Type | Receives |
|---|---|---|
| Brief mindfulness followed by brief mindfulness for non-responders | Experimental | Behavioral: Brief mindfulness1 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. |
| Standard care followed by brief mindfulness for non-responders | Experimental | Behavioral: Brief mindfulness, Other: Standard carePatients 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. |
| Brief mindfulness followed by MORE for non-responders | Experimental | Behavioral: Brief mindfulness, Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)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. |
| Standard care followed by MORE for non-responders | Experimental | Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE), Other: Standard carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief mindfulnessA 15-minute guided mindfulness practice that includes focused attention on breath and body sensations and open monitoring and acceptance of thoughts, emotions, and pain. | Behavioural | Brief mindfulness followed by MORE for non-responders, Brief mindfulness followed by brief mindfulness for non-responders, Standard care followed by brief mindfulness for non-responders |
| 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. | Behavioural | Brief mindfulness followed by MORE for non-responders, Standard care followed by MORE for non-responders |
| Standard carePreoperative 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. | Other | Standard care followed by MORE for non-responders, Standard care followed by brief mindfulness for non-responders |
Primary outcome
Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index
Time frame: Baseline to 9 months
Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis).
5 secondary outcomes
Opioid use
Time frame: Baseline to 9 months
Distress
Time frame: Baseline to 9 months
Defense and Veterans Pain Rating Scale
Time frame: Baseline to 9 months
Opioid misuse
Time frame: Baseline to 9 months
Health-related quality of life
Time frame: Baseline to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina Greenlee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mindfulness and Mindfulness-Oriented Recovery Enhancement (MORE) in people with Knee Pain Chronic, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Mayhew (253.968.2911, rachel.j.mayhew.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (time frame: Baseline to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.