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OpenTrials
Completed

NCT Number: NCT06268197

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yoga intervention

Behavioral

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.

Primary outcomes

  1. Feasibility

    Time frame: Primary endpoint: 6 weeks

    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.

  2. Acceptability

    Time frame: Primary endpoint: 6 weeks

    Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)

Secondary outcomes

  1. Interoceptive Sensibility

    Time frame: Primary endpoint: 6 weeks

    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.

  2. PROMIS Pain Interference

    Time frame: Primary endpoint: 6 weeks

    Short Form 8a

Other outcomes

  1. Interoceptive Accuracy

    Time frame: Primary endpoint: 6 weeks

    Heartbeat Tracking Task

  2. Mindfulness

    Time frame: Primary endpoint: 6 weeks

    Five Facet Mindfulness Questionnaire (FFMQ), planned covariate for interoceptive sensibility

  3. PROMIS Pain Intensity

    Time frame: Primary endpoint: 6 weeks

    Short Form 3a, planned covariate for pain interference.

  4. Quality of Life

    Time frame: Primary endpoint: 6 weeks

    36-Item Short Form Health Survey (SF-36)

  5. Spiritual Wellbeing

    Time frame: Primary endpoint: 6 weeks

    Functional Assessment of Chronic Illness Therapy - Spiritual Wellbeing Scale (FACIT-Sp12)

  6. Pain Impact

    Time frame: Primary endpoint: 6 weeks

    ASCQ Pain Impact Short Form

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Official study title

Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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