Interoception-Based Yoga for Chronic Pain

Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain

The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Yoga Intervention

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Project Coordinator; Phone Number: 217-265-0741; Email: svoss2@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois Urbana-Champaign
      • Contact: Project Coordinator; Phone Number: 217-265-0741; Email: svoss2@illinois.edu
      • Principal Investigator: Neha P Gothe, PhD
      • Sub-Investigator: Steven Petruzzello, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Self-reported chronic pain lasting ≥ 3 months (such as widespread musculoskeletal pain, fibromyalgia, migraine etc.)
• In the past week, has pain interfered with your day-to-day activities? Yes
• Self-reported ambulatory ability without an assistive device
• Self-reported ability to get on and off the floor without assistance.
• No ongoing mind-body practice (<1x/week over the past 6 months).
• Physical Activity Readiness Questionnaire Screen Pass or Physician Consent
• English-speaking
• Able and willing to provide consent
• No plans to move or travel outside the area in the next 2 months

Exclusion Criteria:

• Ages <18 or ≥ 65 at time of screening
• Pain lasting < 3 months
• In the past week, has pain interfered with your day-to-day activities? No
• Use of any assistive device (e.g. cane, walker, wheelchair).
• Inability to get on and off the floor without assistance.
• A consistent ongoing mind-body practice (mindfulness, yoga, meditation, tai chi, qigong), at least 1x/week over the past 6 months
• Physical Activity Readiness Questionnaire Screen Fail or non-consent of physician
• Non-English speaking
• Non-consent
• Plans to move or significant travel outside the area in the next 2 months
• Known pregnancy
• Recent surgery or acute bone, joint or nerve injury (within the past 6 months)
• Severe or progressive neurological conditions such as Parkinson's disease, dementia, multiple sclerosis, or acquired brain injury
• Separate pain-related diagnoses: cancer-related pain, complex regional pain syndrome, postural orthostatic tachycardia syndrome, functional neurological/ movement disorders
• Active or planned worker's compensation or personal injury claim
• Concurrent participation in another interventional study (e.g. physical activity, mind-body or drug trials)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Yoga Intervention; Interoception-based yoga intervention, 2x/week for 6 weeks.

Behavioral: Yoga Intervention; The yoga intervention will consist of twice weekly, in-person, gentle Hatha yoga classes delivered by a certified yoga instructor. Each class will last 60-75 minutes and will include an introduction to the day's topic, an opening breathing/meditation practice, yoga postures, a closing breathing/meditation practice, and end with a savasana pose and intention setting for a home practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Defined as achieving the target recruitment sample (N=25) in a 9-month period, 80% retention (N=20), 70% attendance rate, 70% home practice adherence and no serious adverse events.	Primary endpoint: 6 weeks
Acceptability	Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)	Primary endpoint: 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interoceptive Sensibility	Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). Will take the mean of 5 MAIA-2 Subscales: attention regulation, emotional awareness, self-regulation, body listening, and trusting as the primary measure of preliminary efficacy. Planned post-hoc analyses will evaluate differential changes in all 8 subscales.	Primary endpoint: 6 weeks
PROMIS Pain Interference	Short Form 8a	Primary endpoint: 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interoceptive Accuracy	Heartbeat Tracking Task	Primary endpoint: 6 weeks
Mindfulness	Five Facet Mindfulness Questionnaire (FFMQ), planned covariate for interoceptive sensibility	Primary endpoint: 6 weeks
PROMIS Pain Intensity	Short Form 3a, planned covariate for pain interference.	Primary endpoint: 6 weeks
Quality of Life	36-Item Short Form Health Survey (SF-36)	Primary endpoint: 6 weeks
Spiritual Wellbeing	Functional Assessment of Chronic Illness Therapy - Spiritual Wellbeing Scale (FACIT-Sp12)	Primary endpoint: 6 weeks
Pain Impact	ASCQ Pain Impact Short Form	Primary endpoint: 6 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Investigators: Principal Investigator: Neha P Gothe, PhD, University of Illinois Urbana-Champaign; Principal Investigator: Steven Petruzzello, PhD, University of Illinois Urbana-Champaing

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: IRB23-0329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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