Integration of Mindfulness and Acupuncture After Spine Surgery (I-MASS)

Integration of Mindfulness and Acupuncture After Spine Surgery: Aim 2

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.

Study Overview

• Status: Completed
• Conditions: Laminectomy; Single Level Spinal Fusion; Discetomy
• Intervention / Treatment: Behavioral: Mindfulness training; Other: Acupuncture; Behavioral: Enhanced education

Detailed 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.

I-MASS program plus enhanced education (Intervention) Arm: This arm 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 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). The modules 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.

The initial acupuncture session will occur within one week prior to surgery. The second acupuncture session will occur within the first week following surgery. Afterwards, participants will receive acupuncture 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 acupuncture sessions. 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 acupuncture session. Auricular acupuncture will be the preferred form of acupuncture used. If participants are unable to tolerate auricular acupuncture, they will have the option to receive peripheral acupuncture.

The program consists of enhanced 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 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.

Enhanced Education Arm: Participants in this arm will receive an introductory call from study staff to introduce the participant to the Pattern Health app, discuss how to access the Healthwise educational content, and answer any questions about the program. They will then receive the same course of enhanced educational material as the Intervention arm in the Pattern Health app.

All trial participants 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. All follow-up questionnaires will be administered through the Pattern Health app for participants in both study arms.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Sports Science Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. undergoing single level fusion, discectomy or laminectomy of the cervical or lumbar spine for management of pain
2. 18 years of age or older
3. has access to a smartphone or mobile device (with android or iOS operating system) and internet to complete training and questionnaires.

Exclusion Criteria:

1. 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)
2. undergoing surgery for neoplastic disease
3. current daily opioid use greater than 100mg morphine equivalents
4. unable to receive acupuncture due to injury, infection, or other contraindication to the use of needles at acupuncture sites
5. not possible to attend outpatient clinic for AA follow-up (e.g., from out-of-state)
6. currently practicing mindfulness or receiving acupuncture
7. in Hospice, receiving palliative care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-MASS Program plus Enhanced Education	Behavioral: Mindfulness training; • 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 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). Each mindfulness module is anticipated to last one week and includes a short (4-5 min) introductory video, daily sessions comprised of a 6-8 min guided mediation, and interactive suggestions for how to apply mindfulness within a daily routine (~10-12 min total per daily session).; Other: Acupuncture; This arm also includes up to 8 total acupuncture treatments (1 prior to surgery and up to 7 treatments in the 12 weeks after surgery). Auricular acupuncture will be the preferred form of acupuncture used. This technique involves inserting tiny needles in specific areas of the outer ear to target points believed to influence pain. If participants are unable to tolerate auricular acupuncture, they will have the option to receive peripheral acupuncture.; Behavioral: Enhanced education; • 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. 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.
Active Comparator: Enhanced Education Intervention Only	Behavioral: Enhanced education; • 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ-8)	The CSQ-8 assesses credibility and satisfaction with health-related services (8 items, 4-point Likert, with higher scores indicating higher credibility/satisfaction).	up to 3 months post-surgery
Recruitment	Percentage of contacted patients that are eligible and agree to participate	up to 3 months post-surgery
Data Collection	Percentage of participants who complete self-report follow-up questionnaires at each of the 4 timepoints.	up to 3 months post-surgery
Number of completed acupuncture visits	Percentage of acupuncture visits completed out of 8 possible visits	up to 3 months post-surgery
Number of completed mindfulness modules	Percentage of completed mindfulness modules out of 4 possible in the Pattern Health app	up to 3 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 v2. 0	This profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain and a one-item measure of pain intensity. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.	Baseline (prior to surgery), 2weeks, 6weeks, 3 months post-surgery
Daily Pain Intensity	Daily pain intensity during the week prior to surgery and for two weeks following surgery will be measured with the following two questions: 1) Please rate your worst pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst possible pain), and 2) Please rate your average pain in the last 24 hours on a scale from 0 (no pain) to 10 (worst possible pain). These measures will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.	week before surgery, for 2 weeks after surgery
SPARE Fear Avoidance Short-form	The SPARE-FA short form is a 4 item questionnaires that measures characteristics of pain-related fear avoidance, catastrophizing, and kinesiophobia. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.	Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
Medication Prescriptions	We will collect self-reported information on medication prescriptions for pain (e.g., Opioids, Benzodiazepines, Gabapentin/Neurontin, NSAIDs) at baseline, 6 weeks, and 3 months. We will also collect self-reported pain medication use daily during the first 2 weeks following surgery. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.	Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
Number of hospital readmission's related to spine surgery	ADT alerts in the Epic EHR and periodic chart reviews through 3 months. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.	up to 3 months post-surgery
Number of emergency room visits related to Spine.	ADT alerts in the Epic EHR and periodic chart reviews through 3 months. This measure will be used to assess feasibility of data collection, no formal comparisons will be made across treatment arms.	up to 3 months post-surgery

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Trevor Lentz, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: May 20, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: Pro00114814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No