Clinical trial NCT06268197: Interoception-Based Yoga for Chronic Pain
Official title: Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility
timeFrame: Primary endpoint: 6 weeks
measure: Acceptability
timeFrame: Primary endpoint: 6 weeks
Secondary outcomes:
measure: Interoceptive Sensibility
timeFrame: Primary endpoint: 6 weeks
measure: PROMIS Pain Interference
timeFrame: Primary endpoint: 6 weeks
Other outcomes:
measure: Interoceptive Accuracy
timeFrame: Primary endpoint: 6 weeks
measure: Mindfulness
timeFrame: Primary endpoint: 6 weeks
measure: PROMIS Pain Intensity
timeFrame: Primary endpoint: 6 weeks
measure: Quality of Life
timeFrame: Primary endpoint: 6 weeks
measure: Spiritual Wellbeing
timeFrame: Primary endpoint: 6 weeks
measure: Pain Impact
timeFrame: Primary endpoint: 6 weeks
Locations:
city: Urbana
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Neha P Gothe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois Urbana-Champaing
name: Steven Petruzzello, PhD
role: PRINCIPAL_INVESTIGATOR
References: