NCT06268197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

February 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

February 12, 2024

Last Update Submit

March 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Acceptability

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

    Primary endpoint: 6 weeks

Secondary Outcomes (2)

  • Interoceptive Sensibility

    Primary endpoint: 6 weeks

  • PROMIS Pain Interference

    Primary endpoint: 6 weeks

Other Outcomes (6)

  • Interoceptive Accuracy

    Primary endpoint: 6 weeks

  • Mindfulness

    Primary endpoint: 6 weeks

  • PROMIS Pain Intensity

    Primary endpoint: 6 weeks

  • +3 more other outcomes

Study Arms (1)

Yoga Intervention

EXPERIMENTAL

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

Behavioral: Yoga Intervention

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.

Yoga Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Voss S, Patel I, Skowron C, Petruzzello S, Gothe NP. Interoception-Based Yoga for Chronic Pain: A Pilot Feasibility Study. Glob Adv Integr Med Health. 2025 Nov 20;14:27536130251400362. doi: 10.1177/27536130251400362. eCollection 2025 Jan-Dec.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neha P Gothe, PhD

    University of Illinois Urbana-Champaign

    PRINCIPAL INVESTIGATOR
  • Steven Petruzzello, PhD

    University of Illinois Urbana-Champaing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 20, 2024

Study Start

February 16, 2024

Primary Completion

December 30, 2024

Study Completion

March 24, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations