Clinical trial NCT06429072: Integration of Mindfulness and Acupuncture After Spine Surgery
Official title: Integration of Mindfulness and Acupuncture After Spine Surgery: Aim 2
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Single Level Spinal Fusion
Discetomy
Laminectomy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: up to 3 months post-surgery
measure: Recruitment
timeFrame: up to 3 months post-surgery
measure: Data Collection
timeFrame: up to 3 months post-surgery
measure: Number of completed acupuncture visits
timeFrame: up to 3 months post-surgery
measure: Number of completed mindfulness modules
timeFrame: up to 3 months post-surgery
Secondary outcomes:
measure: PROMIS-29 v2. 0
timeFrame: Baseline (prior to surgery), 2weeks, 6weeks, 3 months post-surgery
measure: Daily Pain Intensity
timeFrame: week before surgery, for 2 weeks after surgery
measure: SPARE Fear Avoidance Short-form
timeFrame: Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
measure: Medication Prescriptions
timeFrame: Baseline (prior to surgery) , 2weeks, 6weeks, 3 months post-surgery
measure: Number of hospital readmission's related to spine surgery
timeFrame: up to 3 months post-surgery
measure: Number of emergency room visits related to Spine.
timeFrame: up to 3 months post-surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sports Science Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Trevor Lentz, PhD
role: PRINCIPAL_INVESTIGATOR
References: