Mindfulness-Based Intervention for Post-Knee Surgery Recovery

(SEMPER Trial)

Overseen By Tina Greenlee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Cognitive impairment, Suicidality, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study aims to reduce chronic opioid use, there might be a focus on changing opioid medication use.

What data supports the effectiveness of the Mindfulness-Based Intervention for post-knee surgery recovery?

While the research does not directly address mindfulness-based interventions, enhanced recovery programs, which include strategies to reduce stress and improve recovery, have shown benefits like quicker recovery and reduced hospital stays. Mindfulness practices, which also aim to reduce stress, may offer similar benefits in post-surgery recovery. ^{1 2 3 4 5}

Is mindfulness-based intervention safe for post-knee surgery recovery?

The research articles provided do not specifically address the safety of mindfulness-based interventions for post-knee surgery recovery. However, enhanced recovery programs, which focus on reducing surgical stress and improving recovery, are generally considered safe and beneficial for patients undergoing surgery. ^{1 2 5 6 7}

How is the Mindfulness-Based Intervention for Post-Knee Surgery Recovery different from other treatments?

This treatment is unique because it combines mindfulness training with elements of cognitive behavioral therapy (CBT) and positive psychology, offering a holistic approach to recovery. Unlike traditional pain management methods, it focuses on enhancing mental well-being and reducing stress, which can help manage pain without relying on medications. ^{8 9 10 11 12}

Eligibility Criteria

This trial is for individuals with chronic knee pain who are TRICARE beneficiaries and scheduled for total knee arthroplasty. They must understand English well enough to follow study procedures but can't join if they have cognitive impairments, prior formal mindfulness training, severe suicidality, recent or planned contralateral TKA, or current cancer.

Inclusion Criteria

TRICARE beneficiary

Facility with the English language that is adequate to complete study procedures

I am scheduled for a knee replacement surgery at a study site.

Exclusion Criteria

I do not have any cognitive issues that prevent me from following study procedures.

I haven't had, nor plan to have, knee replacement surgery on the other leg within 3 months.

I have not undergone any formal mindfulness training.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intervention

Participants attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. Some receive a single-session mindfulness-based intervention (MBI).

1 session

1 visit (in-person)

Postoperative Follow-up and Intervention

At the one-month post-surgical follow-up, non-responders receive either another single session of brief mindfulness or an 8-session intensive MBI-Mindfulness-Oriented Recovery Enhancement (MORE).

8 weeks for MORE intervention

8 visits (in-person) for MORE

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures assessed from baseline to 9 months.

9 months

Treatment Details

Interventions

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

Trial Overview The study tests two mindfulness-based interventions: a single-session before surgery and an intensive 8-week program called MORE after surgery for those not helped by the first session. The goal is to improve post-surgery health and reduce opioid use by enhancing self-regulation.

Participant Groups

Group I: Standard care followed by brief mindfulness for non-responders Experimental Treatment 2 Interventions

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.

Group II: Standard care followed by MORE for non-responders Experimental Treatment 2 Interventions

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.

Group III: Brief mindfulness followed by brief mindfulness for non-responders Experimental Treatment 1 Intervention

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.

Group IV: Brief mindfulness followed by MORE for non-responders Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

Geneva Foundation

Collaborator

Trials

4

Recruited

9,000+

Findings from Research

Enhanced recovery programs have been shown to significantly improve gut function recovery, reduce complications, and shorten hospital stays after surgery, based on randomized trials.

Key components of these programs, such as reduced pre-operative fasting and early post-operative feeding, challenge traditional practices but are backed by strong clinical evidence, suggesting they should become the standard of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after elective colorectal surgery: now the standard of care. Andrews, EJ., McCourt, M., O'Ríordáin, MG.[2021]

In a study of 1,014 patients undergoing elective abdominal aortic surgery, a fast-track recovery program led to 96.6% of patients tolerating clear liquids and 97.3% beginning early ambulation on the same day as surgery, indicating effective postoperative recovery.

The fast-track program resulted in a median hospital stay of just 3 days, with 89.7% of patients experiencing no complications, demonstrating its safety and efficacy in improving surgical outcomes and facilitating earlier discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast-track in abdominal aortic surgery: experience in over 1,000 patients. Brustia, P., Renghi, A., Aronici, M., et al.[2015]

The enhanced recovery approach focuses on optimizing patient outcomes and improving overall patient experience during medical treatment.

Implementing this approach can lead to significant benefits, although specific details on methods and outcomes were not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How enhanced recovery can boost patient outcomes. Driver, A., Lewis, W., Hayward-Sampson, P., et al.[2019]

Enhanced recovery pathways involve using multiple evidence-based interventions together during surgical care, which can lead to improved patient outcomes compared to using these interventions separately.

Implementing these pathways can help streamline recovery processes, reduce complications, and enhance overall patient satisfaction after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising patient management before and after surgery. Roberts, J., Fenech, T.[2010]

Enhanced recovery after surgery programs focus on improving patient outcomes using established medical practices rather than new drugs, aiming for faster recovery and reduced complications.

These programs effectively manage postoperative factors like pain and mobility to minimize surgical stress, leading to shorter hospital stays and lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Enhanced recovery after surgery program]. Taniguchi, H.[2011]

Enhanced recovery after surgery protocols for bariatric surgery can lead to better outcomes, shorter hospital stays, and cost savings, as supported by evidence from various studies.

The review identified effective anesthetic interventions across preoperative, intraoperative, and postoperative phases, including carbohydrate loading, multimodal analgesia, and opioid minimization, which align with the goals of improving surgical care and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. Grant, MC., Gibbons, MM., Ko, CY., et al.[2020]

Fast-track surgery, or enhanced recovery, has been shown to significantly reduce hospital stay durations and improve patient satisfaction while maintaining low complication rates, based on a review of 11 studies up to September 2015.

This approach emphasizes immediate post-surgical mobilization, a multidisciplinary care model, and reduced reliance on opioids, highlighting the active role of patients in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid recovery programmes for hip and knee arthroplasty. An update. Molko, S., Combalia, A.[2018]

Mindfulness-based interventions (MBIs) have been shown to effectively improve a wide range of biopsychosocial conditions, such as depression, anxiety, and stress, and are considered relatively safe for use in various settings like healthcare, schools, and workplaces.

Despite their effectiveness, there is a need for more high-quality research to confirm the benefits of MBIs for certain conditions, such as PTSD and ADHD, and to explore their cost-effectiveness across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions: an overall review. Zhang, D., Lee, EKP., Mak, ECW., et al.[2021]

A study involving surgical patients with chronic pain showed that 71% of participants used a mindfulness meditation app at least once during a 6-week period, indicating a strong interest in mindfulness-based interventions (MBIs) for pain management.

Despite the high interest, only 8% of patients adhered to the recommended usage of 10 minutes per day, highlighting the need to identify barriers to compliance in order to effectively implement non-pharmacologic pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. Diller, ML., Mascaro, J., Haack, C., et al.[2022]

Mindfulness-based interventions (MBIs) significantly reduce postoperative pain in patients undergoing total hip or knee replacement, based on a systematic review of two randomized control trials involving 299 patients.

The pooled analysis showed a substantial effect size of -1.94 in pain scores for MBI groups compared to control groups, suggesting that MBIs could be a valuable non-opioid approach to managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for the Reduction of Postoperative Pain in Hip and Knee Arthroplasty Patients: A Systematic Review and Meta-Analysis. Barton, MF., Groves, J., Guevel, B., et al.[2023]

The study will evaluate two innovative mindfulness-based interventions (MBIs) for chronic pain management in Veterans, aiming to overcome implementation barriers associated with traditional mindfulness-based stress reduction.

The trial will compare the effectiveness of a group-based MBI (Mobile+Group LAMP) and an individual MBI (Mobile LAMP) against usual care, measuring outcomes like pain interference and mental health over 12 months, which could lead to improved treatment options for Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. Burgess, DJ., Evans, R., Allen, KD., et al.[2022]

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM) was developed and validated to assess therapist competence and adherence to the MORE treatment manual, showing high internal consistency and adequate reliability across 40 treatment sessions involving 295 participants.

Higher fidelity in delivering the MORE treatment was linked to significant reductions in opioid misuse, suggesting that the MORE-FM is an effective tool for ensuring treatment integrity and predicting positive clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. Hanley, AW., Garland, EL.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Enhanced recovery after elective colorectal surgery: now the standard of care. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Fast-track in abdominal aortic surgery: experience in over 1,000 patients. [2015]

3. England pubmed.ncbi.nlm.nih.gov

How enhanced recovery can boost patient outcomes. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Optimising patient management before and after surgery. [2010]

5. Japan pubmed.ncbi.nlm.nih.gov

[Enhanced recovery after surgery program]. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. [2020]

7. Spain pubmed.ncbi.nlm.nih.gov

Rapid recovery programmes for hip and knee arthroplasty. An update. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions: an overall review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for the Reduction of Postoperative Pain in Hip and Knee Arthroplasty Patients: A Systematic Review and Meta-Analysis. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. [2022]