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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Integration of Mindfulness and Acupuncture for individuals undergoing Spine Surgery (I-MASS) is a novel combination of integrative treatments to improve post-surgical recovery. This is a single-site, two-arm randomized feasibility and acceptability pilot trial of the I-MASS program plus enhanced patient education compared to enhanced patient education alone in patients undergoing spine surgery. Outcomes data will come from a combination of passive electronic health record data augmented with patient-reported data collected through the Pattern Health app (the mHealth platform used for delivering mindfulness training and collecting data). Outcomes will focus on feasibility and acceptability of I-MASS, feasibility of recruitment and retention strategies, and data collection procedures through both the Pattern Health app and electronic health record. Feasibility will be supported by mindfulness module completion rates, acupuncture visits attended, participant retention, and questionnaire completion rates. Acceptability will be supported by patient-reported satisfaction, acceptability and usability thresholds.

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 Mindfulness-Based Stress Reduction (MBSR) safe for use in humans?

Mindfulness-Based Stress Reduction (MBSR) has been studied in various contexts, including spine surgery and chronic pain, and is generally considered safe for humans. It is a non-drug therapy that focuses on improving awareness of thoughts, emotions, and body sensations, and has been associated with positive outcomes without significant safety concerns. ^{1 2 3 4 5}

How is the treatment Mindfulness-Based Stress Reduction (MBSR) unique for spine surgery recovery?

Mindfulness-Based Stress Reduction (MBSR) is unique because it is a mind-body therapy that focuses on improving mood and activity levels, which can help reduce reliance on prescription opioids after spine surgery. Unlike traditional drug treatments, MBSR involves mindfulness practices that can enhance quality of life and mental health, making it a promising alternative or complement to pharmacological options. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Auricular acupuncture and Mindfulness Based Stress Reduction (MBSR) for spine surgery recovery?

Research shows that Mindfulness-Based Stress Reduction (MBSR) can improve pain and physical function after joint surgeries and may help reduce opioid use in spine surgery patients. Additionally, ear acupuncture has been found to decrease anxiety before surgery, which could aid in recovery. ^{1 2 5 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

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]

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 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]

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]

Citations

1. Scotland 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. [2020]

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

The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Outcomes in Lumbar Spine Degenerative Disease: 3-Month and 12-Month Results of a Pilot Study. [2020]

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

The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Patient-Reported Pain, Disability, Quality of Life, and Prescription Opioid Use in Lumbar Spine Degenerative Disease: A Pilot Study. [2019]

4. 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]

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

The use of auricular acupuncture to reduce preoperative anxiety. [2019]

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

Mindfulness-Based Stress Reduction Program on Chronic Low-Back Pain: A Study Investigating the Impact on Endocrine, Physical, and Psychologic Functioning. [2017]

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

Mindfulness-Based Interventions for Perioperative Pain Management and Opioid Risk Reduction Following Surgery: A Stepped Care Approach. [2022]

8. India pubmed.ncbi.nlm.nih.gov

A Systematic Review of Mindfulness Practices for Improving Outcomes in Chronic Low Back Pain. [2022]

9. New Zealand 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. [2023]