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OpenTrials
Active, Not Recruiting

NCT Number: NCT07196072

A Multi-component, Person-centered, and Yoga-based Coaching Program for Lupus Chronic Pain

This research will assess the feasibility of a tailored yoga coaching program for reducing pain-related symptoms among people with systemic lupus erythematosus.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 Participants may be withdrawn from the study if they start any such therapies during their study participation.

Treatment and study plan

MiPAL

Behavioral

MiPAL participants meet with a coach to co-develop a self-directed yoga practice based on individual preferences and limitations.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Patient Global Impression of Change (PGIC) score

    Time frame: Up to 13 weeks

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Rheumatology Research Foundation

Registry information

Acronym: MiPAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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