Chronic Pain
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Study design
Eligibility
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Primary endpoint: 6 weeks | Defined as \>5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable) |
| Feasibility | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interoceptive Sensibility | 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. |
| PROMIS Pain Interference | Primary endpoint: 6 weeks | Short Form 8a |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Intensity | Primary endpoint: 6 weeks | Short Form 3a, planned covariate for pain interference. |
| Quality of Life | Primary endpoint: 6 weeks | 36-Item Short Form Health Survey (SF-36) |
| Spiritual Wellbeing | Primary endpoint: 6 weeks | Functional Assessment of Chronic Illness Therapy - Spiritual Wellbeing Scale (FACIT-Sp12) |
| Pain Impact | Primary endpoint: 6 weeks | ASCQ Pain Impact Short Form |
| Mindfulness | Primary endpoint: 6 weeks | Five Facet Mindfulness Questionnaire (FFMQ), planned covariate for interoceptive sensibility |
| Interoceptive Accuracy | Primary endpoint: 6 weeks | Heartbeat Tracking Task |
Countries
United States