Integration of Mindfulness and Acupuncture After Spine Surgery — I-MASS  

Laminectomy Clinical Trial

Official title: Integration of Mindfulness and Acupuncture After Spine Surgery: Aim 2

Status Not yet recruiting

Clinical Trial Summary

The Integration of mHealth Mindfulness and auricular Acupuncture (AA) for individuals undergoing Spine Surgery (I-MASS) is a novel combination of integrative treatments to address postsurgical pain.

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 Lift 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.

Clinical Trial Description

Participants will be randomized to one of two study arms: 1) the I-MASS program plus enhanced education or 2) the enhanced education intervention only.

Overview of I-MASS: The I-MASS program includes pre-surgical and post-surgical components. I-MASS begins with one introductory telephone call by a mindfulness coach (co-I Gremore) 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, 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). The initial AA session will occur within one week prior to surgery. The second AA session will occur within the first week following surgery. Afterwards, participants will receive AA in participating community outpatient clinics for up to 8 sessions total within 12 weeks of surgery. The investigators will allow flexibility in scheduling these visits with a window of 5-10 days between AA sessions. Using push notifications, the Pattern Health app will remind patients when they are within their window for AA treatment.

Details of AA delivery: AA will be performed by formally trained and certified acupuncturists in the community contracted with Duke to provide services for this trial. AA will involve the placement of needles in up to 5 sites (Cingulate Gyrus, Thalamus, Omega 2, Shen Men, and Point Zero) on each ear corresponding to the previously developed battlefield acupuncture protocol to treat pain. Points are always inserted in the same order and the number of needles inserted is determined by the patient's change in pain level. The AA protocol includes pain assessment before starting, after each needle is placed as that informs how many needles are placed, and at the end of the session. The protocol will include use of semi-permanent needles (Seirin Pyonex press-tacks (0.2x1.5mm) or ASP needles). These needles can remain in place for several days for continued pain relief. Participants will be instructed to remove the needles 2 days before their next visit, or sooner if site irritation or soreness warrants. Prior research has demonstrated consistency of acupuncture outcomes across different providers, however the specific components of each acupuncture treatment will be recorded according to the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) to allow for post-hoc assessment of treatment fidelity. Follow-up acupuncture visits will be scheduled with the study acupuncturists. If participants are unable to tolerate aurcular acupuncture, they will be offered the option of a more traditional full body acupuncture protocol focused on pain management.

Details of the Pattern Health app and mHealth mindfulness training: Mindfulness training via the Pattern Health app will be modeled after the protocol used in prior studies of this app with patients recovering from critical illness. Introductory call. All participants in the I-MASS treatment arm will receive an initial introductory call with a mindfulness coach. Each ~30-minute introductory call will be composed of four parts: (1) brief discussion about participants' major current stressor(s); (2) rationale and discussion of the didactic focus; (3) practice and review, and (4) discussion about participant's use of mindfulness skills, challenges in applying the skills, how these skills integrate with the use of AA, and how to maintain progress. The coach will answer questions about use and navigation of the app, and review the overall timeline for completion of the self-directed modules. Mindfulness modules. Study participants will complete 4 self-directed mindfulness training modules (called the Lift program) through the Pattern Health app (1 prior to surgery, 3 following surgery). The training will include a guided series of videos, audio files and interactive text features. Each week-long module includes daily sessions comprised of a short (4-5 min) background video, a 6-8 min guided mediation (users could choose either a female or male voice) and interactive suggestions for how to apply mindfulness within their daily routine (~10-12 min total per session). The pre-operative training (module 1) focuses on developing an awareness of breath, which is a fundamental mindfulness technique. Following surgery, participants will initiate training module 2, building awareness of body systems, followed by modules 3 and 4 over the subsequent 2 weeks. Automated activity reminders in the app will alert the participant to complete the daily session. Each module builds upon skills learned in the previous module and participants are encouraged to continue using learned skills and resources within the app after completion of the modules. Acupuncturists will also be trained to facilitate discussion about mindful awareness and non-judgmental thoughts regarding pain, giving participants an opportunity to reflect on their experiences during the AA session.

Enhanced Education: The program consists of education prior to and after surgery for all participants. This will constitute the only intervention in the education only arm. All of the educational material is delivered via the Pattern Health App. All educational content is from the Healtwise.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. Educational topics include learning how to lift and sit when experiencing pain, proper precautions following surgery, how to ease back into daily activities following surgery, and ways to self-manage pain. Education is in the form of short reading materials or videos, all designed to help safely and effectively recover from surgery.

Participants in the trial will not be prevented from receiving any other care deemed necessary by their health care team and surgeon. This program is designed to complement their usual care, not replace it.

Participant involvement with the study will be complete at 3 months following surgery. The will be able to receive up to 8 acupuncture sessions total (cost covered by the study) during their time in the study. All questionnaires will be administered through the Pattern Health app. ;

Related Conditions & MeSH terms

• Laminectomy

• NCT number: NCT06429072
• Study type: Interventional
• Source: Duke University
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: August 1, 2025