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Clinical Trials/NCT06268197
NCT06268197CompletedNot Applicable

Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain

University of Illinois at Urbana-Champaign1 site in 1 country26 target enrollmentStarted: February 16, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Feasibility

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Yoga Intervention

Experimental

Interoception-based yoga intervention, 2x/week for 6 weeks.

Intervention: Yoga Intervention (Behavioral)

Outcomes

Primary Outcomes

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.

Acceptability

Time Frame: Primary endpoint: 6 weeks

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

Secondary Outcomes

  • Interoceptive Sensibility(Primary endpoint: 6 weeks)
  • PROMIS Pain Interference(Primary endpoint: 6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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