Chronic PainNCT06268197
Interoception-Based Yoga for Chronic Pain
A study testing Yoga Intervention in people with Chronic Pain, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- English-speaking
- Able and willing to provide consent
- No plans to move or travel outside the area in the next 2 months
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain
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.
- Conditions
- Chronic Pain
- Being tested
- Yoga Intervention
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention | Experimental | Interoception-based yoga intervention, 2x/week for 6 weeks. Receives: Behavioral: Yoga Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Primary endpoint: 6 weeks
Acceptability
Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)
Measured: Primary endpoint: 6 weeks
Secondary outcomes (2)
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.
Measured: Primary endpoint: 6 weeks
PROMIS Pain Interference
Short Form 8a
Measured: Primary endpoint: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start16 Feb 2024
- Primary completion30 Dec 2024
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha P Gothe, PhD, Principal investigator, University of Illinois Urbana-ChampaignSteven Petruzzello, PhD, Principal investigator, University of Illinois Urbana-Champaing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268197
- Sponsor's protocol ID
- IRB23-0329
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 41282370
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Interoception-Based Yoga for Chronic Pain
- ClinicalTrials.gov ID
- NCT06268197
- Acronym / sponsor ID
- IRB23-0329
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Behavioral: Yoga InterventionInteroception-based yoga intervention, 2x/week for 6 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga InterventionThe 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. | Behavioural | Yoga Intervention |
Primary outcome
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)
2 secondary outcomes
Interoceptive Sensibility
Time frame: Primary endpoint: 6 weeks
PROMIS Pain Interference
Time frame: Primary endpoint: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 41282370Voss 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha P Gothe, PhD principal investigator
University of Illinois Urbana-Champaign
Steven Petruzzello, PhD principal investigator
University of Illinois Urbana-Champaing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Intervention in people with Chronic Pain, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Primary endpoint: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268197, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.