Knee Pain Chronic
Conditions
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).
Interventions
BEHAVIORALBrief 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.
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.
OTHERStandard 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.
Sponsors
The Geneva Foundation
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Our design is a sequential multiple randomization (SMART) study design with 2 treatment phases with a possibility of 2 randomizations per participant.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index | Baseline to 9 months | Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index (min 0, max 240, with higher scores indicating worse osteoarthritis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use | Baseline to 9 months | 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. |
| Distress | Baseline to 9 months | Depression Anxiety and Stress Scale (range from 0 to 63, higher scores indicating worse distress) |
| Defense and Veterans Pain Rating Scale | Baseline to 9 months | 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) |
| Opioid misuse | Baseline to 9 months | Current Opioid Misuse Measure (0 to 68, higher scores indicating higher opioid misuse) |
| Health-related quality of life | Baseline to 9 months | EuroQol EQ-5D (1 to 5, with higher scores indicating lower quality of life) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trait mindfulness | Baseline to 9 months | Five Facet Mindfulness Questionnaire (min 39, max 195, higher scores indicating greater mindfulness) |
| Perceived ability to return to duty | Baseline to 9 months | 3 questions assessing a service member's self-perceived ability to perform military related tasks (pass a required semi-annual physical fitness test, operate under full combat load, and % mission capability) |
| Savoring natural rewards | Baseline to 9 months | Brief savoring inventory (min 4, max 20, higher scores indicating more savoring) |
| Cognitive reappraisal | Baseline to 9 months | Reappraisal subscale of the Cognitive Emotion Regulation Questionnaire (min 4, max 20, higher scores indicating more reappraisal) |
| Pleasant body sensations | Baseline to 9 months | Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations. |
| Self-transcendence | Baseline to 9 months | Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65) |
| Positive affect | Baseline to 9 months | Positive affect measured by numeric rating scale, with higher scores indicating higher positive affect (min 0, max 10) |
| Mindful reinterpretation of pain sensations | Baseline to 9 months | Mindful reinterpretation of pain sensations (min 0, max 54, with higher scores indicating greater mindful reappraisal of pain) |
| Heart rate variability | Baseline,1 month, 3 months | Change in HRV (mindfulness - resting baseline, higher values representing more HRV) |
Countries
United States
Contacts
Primary ContactRachel Mayhew
Backup ContactTina Greenlee
Outcome results
None listed