Mindfulness Meditation for Chronic Pain

Overseen By Radha Korupolu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: No internet, Visual/hearing impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a 6-week app-guided mindfulness meditation program can reduce pain and improve mood in people with chronic pain, specifically those with a spinal cord injury. Participants will follow either the mindfulness meditation program or a similar health education program. It targets individuals who have had a spinal cord injury for at least six months and experience ongoing pain. Those with regular internet access and an understanding of English may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance pain management strategies for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the study staff.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness meditation is generally safe for most people. A 2017 review of 30 studies with over 2,500 participants found that mindfulness meditation helps reduce chronic pain. Importantly, these studies did not report any major safety concerns.

Mindfulness meditation involves focusing on the present moment, often through breathing exercises and observing thoughts. As a non-drug approach, it poses less risk than many traditional treatments. Participants in these studies did not report any significant negative side effects.

Overall, mindfulness meditation appears well-tolerated, and existing studies have not identified any major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness meditation for chronic pain is unique because it offers a non-drug approach to managing discomfort. Unlike typical treatments like pain relievers or physical therapy, mindfulness meditation focuses on training the mind to process pain differently, potentially reducing the perception of pain itself. This technique promotes a holistic method that not only aims to alleviate pain but also enhances overall well-being, making it an appealing option for those seeking alternatives to medication. Researchers are excited because it could provide a sustainable, side-effect-free solution for chronic pain sufferers.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research shows that mindfulness meditation, which participants in this trial may receive, can help people with chronic pain feel better. Studies have found that it often leads to a small reduction in pain compared to other treatments. One study discovered that programs focused on mindfulness can gradually improve the perceived intensity of pain. People with chronic pain have noticed positive changes with mindfulness-based pain management, although more research is needed. The evidence suggests that mindfulness meditation could significantly aid in managing chronic pain. ^{3 4 6 7 8}

Who Is on the Research Team?

Radha Korupolu, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injury who experience chronic pain. Participants should be interested in trying a mobile app-based intervention to help manage their pain and improve mental health.

Inclusion Criteria

Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys

I have had pain for at least 3 months that feels 4/10 or worse.

I have had a spinal cord injury for at least 6 months.

Exclusion Criteria

I understand the study details after answering questions about it.

Lack of daily internet access

Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week app-guided mindfulness meditation intervention or a health education control condition

6 weeks

Follow-up

Participants are monitored for changes in pain intensity, pain interference, depression, and anxiety after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Education Active Control Intervention
• Mindfulness meditation (MM) Intervention

Trial Overview The study tests if a 6-week mindfulness meditation (MM) program, delivered through an app, can reduce pain and emotional distress better than a general health education program also provided via an app.

How Is the Trial Designed?

Group I: Mindfulness meditation (MM) Experimental Treatment 1 Intervention

Group II: Active Control (AC) Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

The Mindfulness-Based Chronic Pain Management (MBCPM) program showed feasibility in a study with 31 veterans, leading to significant improvements in pain catastrophizing scores, indicating better coping strategies, although pain intensity itself did not significantly change.

Qualitative feedback from participants highlighted feelings of connection, increased awareness, and a sense of control, suggesting that the program may enhance overall quality of life for veterans dealing with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Intervention for Veterans Managing Chronic Pain. Chen, SP., Liu, HT., Appelt, JC., et al.[2023]

A 10-week mindfulness meditation program for 90 chronic pain patients led to significant reductions in pain perception, mood disturbances, and psychological symptoms like anxiety and depression, along with increased self-esteem and activity levels.

Improvements were maintained for up to 15 months after training, indicating the long-term benefits of mindfulness meditation, while a comparison group receiving traditional treatments showed no significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical use of mindfulness meditation for the self-regulation of chronic pain. Kabat-Zinn, J., Lipworth, L., Burney, R.[2022]

Mindfulness-based meditation has been shown to effectively reduce chronic pain, making it a valuable option for patients who do not respond well to traditional medications or surgeries.

Research indicates that mindfulness interventions may work through specific neural mechanisms, providing both immediate and long-lasting pain relief for individuals suffering from chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Meditation in the Treatment of Chronic Pain. Brandel, MG., Lin, C., Hennel, D., et al.[2022]

Mindfulness-based interventions have been shown to effectively reduce chronic pain intensity and improve overall quality of life, based on a review of 72 systematic reviews and clinical trials.

These interventions can also support individuals with substance use disorders and help maintain smoking abstinence when used alongside standard treatments, indicating their versatility in managing co-occurring health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 2: Clinical Implications for Chronic Pain, Substance Misuse, and Insomnia. Khusid, MA., Vythilingam, M.[2018]

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]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program was found to be as effective as a multidisciplinary pain intervention (MPI) program in reducing pain intensity and pain-related distress in patients with chronic pain, based on a study of 99 participants.

Both interventions led to statistically significant improvements in pain and mood symptoms, but the overall differences between MBSR and MPI were not significant, indicating that both approaches can be beneficial for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial. Wong, SY., Chan, FW., Wong, RL., et al.[2015]

A pilot study involving 147 persistent pain patients tested a brief mindfulness-based intervention (MBI) and found it feasible to recruit participants, although there were no significant immediate effects on pain severity.

The MBI group reported greater 'usefulness' of the intervention at 1 week and improved pain self-efficacy at 1 month compared to the control group, suggesting potential long-term benefits of mindfulness practices for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of a brief mindfulness-based intervention for those with persistent pain. Howarth, A., Riaz, M., Perkins-Porras, L., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27658913/

Mindfulness Meditation for Chronic Pain: Systematic ... We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5368208/

Mindfulness Meditation for Chronic Pain: Systematic Review ... We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904225001225

Effect of Mindfulness-Based Stress Reduction on Patients ... The results of this RCT indicate that MBSR programs may play a positive role in improving intensity of pain, within 13 months for patients with chronic pain.

4. link.springer.com link.springer.com/article/10.1007/s12671-022-02023-1

Mindfulness-Based Pain Management (MBPM) for Chronic ... Mindfulness-based pain management (MBPM) has evidenced significant positive changes in patients with chronic pain, but so far, no RCT study has been conducted.

5. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03383-2

The effects of telehealth-delivered mindfulness meditation ... The primary outcome for the trial was pain interference. Secondary outcomes were pain intensity, physical function, mood (positive and negative ...

6. nccih.nih.gov nccih.nih.gov/health/meditation-and-mindfulness-effectiveness-and-safety

Meditation and Mindfulness: Effectiveness and Safety | NCCIH A 2017 analysis of 30 studies (2,561 participants) found that mindfulness meditation was more effective at decreasing chronic pain than several ...

7. rand.org rand.org/pubs/research_reports/RR1317.html

Mindfulness Meditation for Chronic Pain Mindfulness meditation was associated with a small effect of improved pain symptoms compared with control groups in a meta-analysis of 24 randomized controlled ...

8. academic.oup.com academic.oup.com/painmedicine/article/16/4/641/2460516

Effects of Mindfulness Meditation on Chronic Pain A standardized mindfulness program (MBSR) contributes positively to pain management and can exert clinically relevant effects on several important dimensions.