Mindfulness and Acupuncture for Spine Surgery Recovery

(I-MASS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Opioids

Disqualifiers: Schizophrenia, Dementia, Traumatic brain injury, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining mindfulness exercises and acupuncture can improve recovery after spine surgery. Participants are divided into two groups: one receives Mindfulness-Based Stress Reduction (MBSR) training and auricular acupuncture, while the other receives educational materials about surgery recovery. The trial aims to assess participants' satisfaction with these treatments and their ease of use. It suits individuals undergoing specific spine surgeries who own a smartphone or tablet and can visit a clinic for acupuncture follow-ups. As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods after spine surgery.

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, if you are using daily opioids greater than 100mg morphine equivalents, you may not be eligible to participate.

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

Research has shown that Mindfulness-Based Stress Reduction (MBSR) is generally safe for individuals who have undergone spine surgery. Studies indicate it can help manage pain and reduce stress post-surgery without causing serious side effects. Participants have reported experiencing less pain and stress after using MBSR.

For auricular acupuncture, which involves placing needles in the ear, most side effects are minor. These may include slight pain at the needle site, dizziness, or minor bleeding. Overall, it is considered a safe method for managing pain after back surgery.

Both treatments, MBSR and auricular acupuncture, aim to aid recovery and pain management following spine surgery. Most individuals tolerate them well, making these treatments promising options for post-surgery care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines Mindfulness Based Stress Reduction (MBSR) with auricular acupuncture (AA) to enhance spine surgery recovery. Unlike standard care that usually focuses on physical rehabilitation and pain management through medications, this innovative approach integrates mental well-being practices via a mobile app, offering a holistic recovery experience. The use of MBSR helps manage stress and anxiety, potentially speeding up recovery, while auricular acupuncture targets pain relief through ear pressure points. This comprehensive method aims to improve overall patient outcomes by addressing both mental and physical aspects of recovery.

What evidence suggests that the I-MASS program's treatments could be effective for spine surgery recovery?

Research has shown that Mindfulness-Based Stress Reduction (MBSR), which participants in this trial may receive, can aid in alleviating back pain and enhancing recovery after spine surgery. Studies have found that patients using MBSR report less pain and greater ease of movement compared to those receiving usual care. MBSR includes simple activities like meditation and breathing exercises, which help manage pain and stress.

Auricular acupuncture, another treatment option in this trial, targets specific points on the ear and has also been shown to reduce pain after back surgery. Several studies have found that it can lower pain levels and reduce the need for pain medication in the days following surgery.

Together, these treatments offer promising ways to ease pain and improve recovery after spine surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Trevor Lentz, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals undergoing spine surgery, such as spinal fusion or treatment for herniated discs. Participants should be willing to use a mobile health app and attend mindfulness and acupuncture sessions. Specific details on who can't join are not provided.

Inclusion Criteria

I am having spine surgery to manage pain.

Has access to a smartphone or mobile device (with android or iOS operating system) and internet to complete training and questionnaires.

Exclusion Criteria

I am in hospice care.

Have conditions making consent, follow-up data collection and/or use of the intervention prohibitive (e.g., Non-English speaking, serious psychiatric conditions [i.e., schizophrenia], traumatic brain injury, or dementia-type illness)

I am scheduled for surgery to remove a tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 introductory call

Pre-operative Mindfulness Training

Participants complete a pre-operative mindfulness module focusing on developing an awareness of breath

1 week

1 session (virtual)

Post-operative Mindfulness and Acupuncture

Participants complete 3 mindfulness modules and up to 8 acupuncture sessions over 12 weeks

12 weeks

8 acupuncture sessions (in-person), multiple virtual mindfulness sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of follow-up questionnaires

3 months

Follow-up questionnaires administered through the app

What Are the Treatments Tested in This Trial?

Interventions

• Auricular acupuncture
• Mindfulness Based Stress Reduction (MBSR)

Trial Overview

The study tests if combining Mindfulness Based Stress Reduction (MBSR) and auricular acupuncture with enhanced education helps manage post-surgery pain better than just education alone. It's a small-scale test to see if this approach is workable and acceptable to patients.

How Is the Trial Designed?

Group I: I-MASS Program plus Enhanced Education Experimental Treatment 3 Interventions

Integrated program that combines Mindfulness Based Stress Reduction (MBSR) delivered via mobile app (mHealth) with auricular Acupuncture (AA) in individuals undergoing Spine Surgery (I-MASS) plus enhanced education. I-MASS begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app, discuss the benefits of combining mindfulness and AA (auricular acupuncture), discuss how to access the Healthwise educational content, and lead a brief (~10 min) mindfulness exercise, as desired. Thereafter, participants will complete 4 self-directed mindfulness modules through the Pattern Health app (1 prior to surgery, 3 following surgery).

Group II: Enhanced Education Intervention Only Active Control 1 Intervention

The program consists of education prior to and after surgery for all participants. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healthwise.net Duke Health Library (https://www.healthwise.net/dukehealth/Content) and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Mindfulness-based stress reduction (MBSR) techniques significantly improve subjective pain scores and quality of life in chronic pain patients, particularly those with chronic low back pain, based on a review of 12 empirical studies.

Despite some limitations such as small sample sizes and varied pain measurement tools, the evidence suggests that MBSR can be an effective non-pharmacological treatment option for managing chronic pain and enhancing mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. Smith, SL., Langen, WH.[2022]

A culturally adapted mindfulness-based stress reduction (MBSR) program significantly reduced pain catastrophizing in Chinese adults with chronic pain, showing a moderate effect immediately after treatment, although this effect did not persist at the 3-month follow-up.

The MBSR group also demonstrated improvements in pain interference and perceived stress compared to the control group, along with unique changes in brain activity as indicated by fMRI, suggesting potential neurobiological benefits from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising Subjective and Objective Benefits of Modified Mindfulness-Based Stress Reduction Training for Chinese Adults with Chronic Pain: A Pilot Randomized Control Study. Chen, S., Gao, X., Shi, T., et al.[2023]

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]

In a study involving 127 participants undergoing total joint arthroplasty, those who completed an eight-week Mindfulness-Based Stress Reduction (MBSR) program reported significantly greater improvements in knee pain and physical function at 12 months post-surgery compared to those receiving usual care.

The MBSR group experienced a mean reduction in knee pain of 10.3 points and improved function by 10.2 points on the WOMAC scale, indicating that MBSR can be an effective intervention for enhancing recovery in patients with psychological distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: A randomised controlled trial. Dowsey, M., Castle, D., Knowles, S., et al.[2020]

Mindfulness-based interventions can effectively reduce preoperative pain and anxiety, potentially preventing chronic pain and opioid misuse after surgery, as supported by numerous randomized clinical trials.

A stepped care approach to mindfulness treatment is proposed, where initial brief mindfulness techniques are used for preoperative patients, followed by more extensive interventions for those with ongoing pain or opioid dependence post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Perioperative Pain Management and Opioid Risk Reduction Following Surgery: A Stepped Care Approach. Roberts, RL., Hanley, AW., Garland, EL.[2022]

Citations

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The most frequently reported adverse events were tenderness or pain at insertion, dizziness, local discomfort, minor bleeding and nausea, and so forth.

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We conclude that AA is an effective, safe, cost-effective, non-invasive nursing intervention that can improve pain, neuropathy, and sleep in patients on PSPS.