Interoception-Based Yoga for Chronic Pain

Chronic Pain Clinical Trial

Official title:

Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268197
• Other study ID #: IRB23-0329
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: University of Illinois at Urbana-Champaign
• Contact: Project Coordinator
• Phone: 217-265-0741
• Email: svoss2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	University of Illinois Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interoceptive Accuracy	Heartbeat Tracking Task	Primary endpoint: 6 weeks
Other	Mindfulness	Five Facet Mindfulness Questionnaire (FFMQ), planned covariate for interoceptive sensibility	Primary endpoint: 6 weeks
Other	PROMIS Pain Intensity	Short Form 3a, planned covariate for pain interference.	Primary endpoint: 6 weeks
Other	Quality of Life	36-Item Short Form Health Survey (SF-36)	Primary endpoint: 6 weeks
Other	Spiritual Wellbeing	Functional Assessment of Chronic Illness Therapy - Spiritual Wellbeing Scale (FACIT-Sp12)	Primary endpoint: 6 weeks
Other	Pain Impact	ASCQ Pain Impact Short Form	Primary endpoint: 6 weeks
Primary	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
Primary	Acceptability	Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)	Primary endpoint: 6 weeks
Secondary	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
Secondary	PROMIS Pain Interference	Short Form 8a	Primary endpoint: 6 weeks