SLE (Systemic Lupus)MiPALNCT07196072
A Multi-component, Person-centered, and Yoga-based Coaching Program for Lupus Chronic Pain
A study testing MiPAL in people with SLE (Systemic Lupus) and Chronic Pain, run by University of Michigan at 1 site in United States.
Trial summary
This research will assess the feasibility of a tailored yoga coaching program for reducing pain-related symptoms among people with systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE (Systemic Lupus), Chronic Pain
- What is being tested?
- MiPAL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions.
- Diagnosed with systemic lupus erythematosus (SLE). In this study, SLE is classified as meeting the 2019 European League Against Rheumatism/American College of Radiology (ACR) criteria for SLE.
- Stable doses of lupus-related medications, including prednisone, for 3 months prior to study entry.
- Reports pain lasting ≥ 3 months and has a sum of ≥8 on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Pain Interference items (assessed at screening).
- Willingness to attend all study visits, including attending recorded virtual coaching sessions for the duration of study.
- Willingness to engage in yoga practices outlined in the MiPAL program.
- Access to necessary resources for participating in a remote intervention, including a smartphone, computer, or tablet with internet
Who cannot join
- Taking >10 mg of prednisone (or equivalent steroid dose) per day.
- Unable to attend study visits.
- Pregnancy.
- Concurrent participation in other behavioral, psychotherapeutic, or pharmacological trials.
- Any impairment, activity, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol. For example, any condition that impairs the ability to give consent or participate fully in the study.
- Currently engaged in or starting any therapies (physical, occupational, CBT, psychotherapy, etc.) that are focused on managing chronic pain. Participants may be withdrawn from the study if they start any such therapies during their study participation.
Trial locations and contacts
1 site in 1 country.
About this study
This research will assess the feasibility of a tailored yoga coaching program for reducing pain-related symptoms among people with systemic lupus erythematosus.
- Conditions
- SLE (Systemic Lupus), Chronic Pain
- Being tested
- MiPAL
- Medical subject headings
- Lupus Erythematosus, Systemic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiPALBehavioural
MiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations.
| Study group | Role | What they receive |
|---|---|---|
| MiPAL participant | Experimental | All study participants who meet eligibility criteria. Receives: Behavioral: MiPAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants recruited
Defined by the number of participants who enroll in the study compared to the target recruitment number (i.e., n=15 anticipated)
Measured: Baseline, when participants complete informed consent and enroll in the study.
Proportion of enrolled participants who complete the study protocol
The proportion of enrolled participants who complete the study protocol (i.e., study activities for the 13-week follow up)
Measured: End of participation, up to 13 weeks
Secondary outcomes (1)
Patient Global Impression of Change (PGIC) score
This is a 1-item survey that measures patient perceptions of intervention success. This survey is scored from 1 to 7, where lower scores indicate a better outcome.
Researchers will consider the intervention to make participants feel better overall if their score = 1, 2, or 3
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE (Systemic Lupus)Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single site, single-arm, and open label feasibility study.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Principal investigator, Dominique Lynn Kinnett-Hopkins, University of Michigan
- Investigators
- Dominique Kinnett-Hopkins, PhD, Principal investigator, University of MichiganRachel Bergmans, MPH, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196072
- Sponsor's protocol ID
- HUM00264850
- Acronym
- MiPAL
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-component, Person-centered, and Yoga-based Coaching Program for Lupus Chronic Pain
- ClinicalTrials.gov ID
- NCT07196072
- Acronym / sponsor ID
- MiPAL / HUM00264850
- Conditions
- SLE (Systemic Lupus), Chronic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 29 Sep 2025 (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.
This research will assess the feasibility of a tailored yoga coaching program for reducing pain-related symptoms among people with systemic lupus erythematosus.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single site, single-arm, and open label feasibility study.
| Arm | Type | Receives |
|---|---|---|
| MiPAL participant | Experimental | Behavioral: MiPALAll study participants who meet eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to read and speak English sufficiently to allow for informed consent and active participation in the intervention sessions.
- Diagnosed with systemic lupus erythematosus (SLE). In this study, SLE is classified as meeting the 2019 European League Against Rheumatism/American College of Radiology (ACR) criteria for SLE.
- Stable doses of lupus-related medications, including prednisone, for 3 months prior to study entry.
- Reports pain lasting ≥ 3 months and has a sum of ≥8 on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Pain Interference items (assessed at screening).
- Willingness to attend all study visits, including attending recorded virtual coaching sessions for the duration of study.
Key exclusion criteria (6 listed)
- Taking >10 mg of prednisone (or equivalent steroid dose) per day.
- Unable to attend study visits.
- Pregnancy.
- Concurrent participation in other behavioral, psychotherapeutic, or pharmacological trials.
- Any impairment, activity, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol. For example, any condition that impairs the ability to give consent or participate fully in the study.
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 |
|---|---|---|
| MiPALMiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations. | Behavioural | MiPAL participant |
Primary outcome
Proportion of participants recruited
Time frame: Baseline, when participants complete informed consent and enroll in the study.
Defined by the number of participants who enroll in the study compared to the target recruitment number (i.e., n=15 anticipated)
Proportion of enrolled participants who complete the study protocol
Time frame: End of participation, up to 13 weeks
The proportion of enrolled participants who complete the study protocol (i.e., study activities for the 13-week follow up)
1 secondary outcome
Patient Global Impression of Change (PGIC) score
Time frame: Up to 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Dominique Kinnett-Hopkins, PhD principal investigator
University of Michigan
Rachel Bergmans, MPH, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiPAL in people with SLE (Systemic Lupus) and Chronic Pain, run by University of Michigan 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants recruited (time frame: Baseline, when participants complete informed consent and enroll in the study.). 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?
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 3 Feb 2026.