Integration of Mindfulness and Acupuncture After Spine Surgery

NCT06429072 | Completed DMC

• 1 other identifier: Pro00114814
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Single Level Spinal Fusion; Discetomy; Laminectomy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• PROMIS-29 v2. 0

  Baseline (prior to surgery), 2weeks, 6weeks, 3 months post-surgery

• Daily Pain Intensity

  week before surgery, for 2 weeks after surgery

• SPARE Fear Avoidance Short-form

  Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery

• Medication Prescriptions

  Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery

• Number of hospital readmission's related to spine surgery

  up to 3 months post-surgery

Study Arms (2)

I-MASS Program plus Enhanced Education

EXPERIMENTAL

Behavioral: Mindfulness training; Other: Acupuncture; Behavioral: Enhanced education

Enhanced Education Intervention Only

ACTIVE COMPARATOR

Behavioral: Enhanced education

Interventions

Mindfulness training BEHAVIORAL

• 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).

I-MASS Program plus Enhanced Education

Acupuncture OTHER

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.

I-MASS Program plus Enhanced Education

Enhanced education BEHAVIORAL

• 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.

Enhanced Education Intervention Only; I-MASS Program plus Enhanced Education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Trevor Lentz, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: May 24, 2024
• Study Start: August 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)