Meditation + Pain Management for Chronic Knee Pain

Overseen By Patrick Finan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Opioids

Disqualifiers: Pregnancy, Schizophrenia, Substance use, others

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

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use opioids weekly or more often, you may not be eligible to participate.

What data supports the effectiveness of the treatment Meditation + Pain Management for Chronic Knee Pain?

Research shows that mindfulness meditation, a component of the treatment, can help manage chronic pain by reducing pain levels and improving quality of life. Additionally, self-management programs, which include education and mindfulness practices, have shown modest improvements in pain and emotional well-being for chronic pain patients. ^{1 2 3 4 5}

Is meditation safe for managing chronic knee pain?

Meditation, including mindfulness and virtual reality meditation, is generally considered safe for managing chronic pain, with studies showing positive effects on pain and mood without significant safety concerns. ^{1 2 6 7 8}

How is the Meditation + Pain Management treatment for chronic knee pain different from other treatments?

This treatment is unique because it combines pain self-management education with savoring meditation, focusing on mindfulness and generating positive emotions, which is different from traditional pain treatments that often rely on medication or physical therapy alone. ^{9 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to investigate the efficacy of a positive affect enhancing intervention designed to reduce pain and augment reward system function in knee osteoarthritis (KOA) patients undergoing total knee arthroplasty (TKA). The scientific premise is that patient use of a positive emotion generative practice - savoring meditation, which has been demonstrated to reduce pain in experimental laboratory settings, enhanced with a pain neuroscience education component about reward system dysfunction as a chronic pain mechanism - is optimally suited to reduce postsurgical pain and augment reward system functioning relative to a Pain Self-Management and Education (PSME) condition. We will randomize 150 patients with KOA undergoing unilateral TKA to a brief, 4-session (20-30 minutes each) course of Savoring Meditation (SM; n = 75) or PSME (n = 75) delivered remotely by trained interventionists in a one-on-one format. We will assess pain and as well as pain-related risk and protective factors both via questionnaire and via weeklong ecological momentary assessment (EMA) data bursts on the following schedule: baseline, post-surgery, and 3-month follow-up. In addition, participants will attend laboratory testing sessions at baseline and 6-weeks post-surgery, during which affective pain modulation and electroencephalographic (EEG) brain biomarkers associated with pain and affect will be recorded. Participants in SM be encouraged to practice their savoring for 5 minutes/day during the week following surgery, as well as to use it to manage pain flares in a self-directed manner.

Eligibility Criteria

This trial is for adults aged 18-85 who are scheduled for knee replacement surgery due to osteoarthritis and can follow the study plan. It's not for those with severe alcohol/substance abuse, major psychiatric issues, recent other knee surgeries, frequent opioid use (except certain types), or in vulnerable groups like pregnant women.

Inclusion Criteria

I am willing and able to follow the study's schedule and procedures.

I am diagnosed with knee osteoarthritis and have a plan for knee replacement surgery.

Exclusion Criteria

I have had a total knee replacement.

Current unstable, severe medical comorbidity

Current severe psychiatric comorbidity (e.g., schizophrenia, psychosis, or other unstable psychiatric disorder)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-session intervention of either Savoring Meditation or Pain Self-Management and Education, delivered remotely by trained interventionists.

4 weeks

4 sessions (remote)

Post-surgery Monitoring

Participants are encouraged to practice savoring meditation daily and manage pain flares post-surgery. Pain and related factors are assessed via questionnaires and ecological momentary assessment.

6 weeks

Laboratory testing at 6 weeks post-surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months post-surgery.

3 months

Treatment Details

Interventions

• Pain Self-Management and Education
• Savoring Meditation

Trial Overview The study tests if savoring meditation combined with pain education can help manage pain better than just pain self-management and education after knee surgery. Participants will be randomly assigned to one of these two approaches and followed up through questionnaires and brain activity measurements.

Participant Groups

Group I: Savoring Meditation Experimental Treatment 1 Intervention

A 4-session meditation intervention in which participants are trained to generate positive emotional states and focus their awareness on those states throughout the meditation.

Group II: Pain Self-Management and Education Experimental Treatment 1 Intervention

Education Control

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Findings from Research

The Chronic Pain Self-Management Programme (CPSMP) was found to be feasible and well-received by participants, with over 75% recommending it to others, indicating its potential for broader implementation.

Participants in the CPSMP experienced significant and stable improvements in pain, disability, and psychological factors like anxiety and depression over a 5-month follow-up, although the overall changes were modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. Mehlsen, M., Heegaard, L., Frostholm, L.[2022]

A study involving patients with chronic pain found that app-delivered mindfulness meditation led to significant improvements in social functioning and reduced feelings of helplessness, indicating its potential as a self-management tool for chronic pain.

Despite the benefits, adherence to the mindfulness app was low, with less than half of participants following the program, suggesting that factors like educational background and perceived pressure to enroll may influence engagement with the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, wait-list-controlled pilot study of app-delivered mindfulness for patients reporting chronic pain. Mascaro, JS., Singh, V., Wehrmeyer, K., et al.[2022]

An observational study involving 200 patients with chronic pain showed that Internet-based self-management education led to modest improvements in pain, anxiety, and quality of life over six months.

Notably, 45% of patients with moderate to severe pain reported a reduction to mild pain levels after the intervention, indicating that online resources can effectively support pain management for those unable to access traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding Ways to Lift Barriers to Care for Chronic Pain Patients: Outcomes of Using Internet-Based Self-Management Activities to Reduce Pain and Improve Quality of Life. Rod, K.[2018]

The Stanford Chronic Pain Self-Management Programme (CPSMP) did not significantly reduce pain-related disability or healthcare costs in a study of 424 adults with chronic pain, indicating it may not be an effective treatment for this issue.

While there were small improvements in emotional distress and illness worry three months after the program, these changes were clinically insignificant, suggesting that the CPSMP may not provide meaningful benefits for individuals suffering from chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a lay-led, group-based self-management program for patients with chronic pain: a randomized controlled trial of the Danish version of the Chronic Pain Self-Management Programme. Mehlsen, M., Hegaard, L., Ørnbøl, E., et al.[2023]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

A pilot study involving 19 older adults (aged 60+) demonstrated that a 10-minute virtual reality (VR) meditation program significantly reduced knee pain intensity both during and after the session, with effects lasting up to 24-48 hours.

The VR meditation not only alleviated pain but also improved participants' mood and daily functioning, indicating that it is a feasible and effective nonpharmacological treatment for chronic knee pain in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility and effectiveness of virtual reality meditation on reducing chronic pain for older adults with knee osteoarthritis. Sarkar, TD., Edwards, RR., Baker, N.[2022]

Open monitoring (OM) meditation techniques show promise in reducing both sensory and emotional aspects of pain, while focused attention (FA) practices are generally less effective for pain relief.

The neural mechanisms involved in OM suggest that practitioners can focus on pain while suppressing other thoughts, aligning with mindfulness principles, and there is potential for further exploration of compassion meditation as a pain management technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditative analgesia: the current state of the field. Grant, JA.[2022]

Pain neuroscience education (PNE) shows limited short-term and medium-term effectiveness in reducing chronic musculoskeletal pain and disability, with low clinical relevance based on a review of 12 randomized controlled trials involving 755 participants.

PNE is more effective in addressing kinesiophobia and pain catastrophizing, particularly in the short and medium term, and key components like allowing patients to share their stories can enhance their experience and help them cope better with their pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. Watson, JA., Ryan, CG., Cooper, L., et al.[2020]

Exercise and movement should be prioritized as the main intervention for managing chronic pain, rather than relying solely on pain neuroscience education (PNE) or other therapies.

PNE should be used as a supportive tool to encourage increased participation in exercise, as enhancing knowledge and skills in pain management can lead to better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revisiting the Provision of Pain Neuroscience Education: An Adjunct Intervention for Patients but a Primary Focus of Clinician Education. Louw, A., Sluka, KA., Nijs, J., et al.[2021]

Pain neuroscience education (PNE) has been shown to effectively reduce pain, disability, and healthcare utilization based on high-quality randomized controlled trials and systematic reviews.

Despite its proven efficacy in controlled studies, there is limited knowledge about how to apply PNE in real clinical settings, highlighting the need for further research into its practical implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical application of teaching people about pain. Louw, A., Zimney, K., O'Hotto, C., et al.[2022]

A systematic review of nine studies on educational interventions for chronic pain found that education alone does not significantly reduce pain or disability in adults, with pooled data showing no improvement compared to usual care.

The only positive outcome was observed with pain neurophysiology education (PNE), which showed a decrease in disability and improved knowledge about pain, but the evidence is not strong enough to recommend PNE as a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. Geneen, LJ., Martin, DJ., Adams, N., et al.[2022]

A redesigned, shorter self-management education program for musculoskeletal conditions led to small but statistically significant improvements in pain, health distress, and self-efficacy among participants, based on a study with a 47% response rate (n=102).

The program, which incorporates motivational interviewing and adult learning principles, highlights the importance of community-based education in managing chronic musculoskeletal conditions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Take Charge of Pain: evaluating a community-targeted self-management education program for people with musculoskeletal pain. Hoon, E., Smith, K., Black, J., et al.[2017]

The pilot study of the Chronic Knee Pain Program showed potential benefits for obese adults with chronic knee pain, including a decrease in body mass index (BMI) and improvements in depression symptom severity and physical activity levels, despite a small sample size of only six participants completing the program.

Results indicated a slight reduction in mean BMI over time, suggesting that self-management strategies may help improve the overall well-being of individuals with chronic knee pain, but further research with a larger group is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Chronic Knee Pain Program: A self-management model. Ventura, J., Sobczak, J., Chung, J.[2018]

References

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

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. [2022]

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

Randomized, wait-list-controlled pilot study of app-delivered mindfulness for patients reporting chronic pain. [2022]

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

Finding Ways to Lift Barriers to Care for Chronic Pain Patients: Outcomes of Using Internet-Based Self-Management Activities to Reduce Pain and Improve Quality of Life. [2018]

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

The effect of a lay-led, group-based self-management program for patients with chronic pain: a randomized controlled trial of the Danish version of the Chronic Pain Self-Management Programme. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

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

The feasibility and effectiveness of virtual reality meditation on reducing chronic pain for older adults with knee osteoarthritis. [2022]

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

Meditative analgesia: the current state of the field. [2022]

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

Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. [2020]

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

Revisiting the Provision of Pain Neuroscience Education: An Adjunct Intervention for Patients but a Primary Focus of Clinician Education. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The clinical application of teaching people about pain. [2022]

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

Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

Take Charge of Pain: evaluating a community-targeted self-management education program for people with musculoskeletal pain. [2017]

13. England pubmed.ncbi.nlm.nih.gov

The Chronic Knee Pain Program: A self-management model. [2018]