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Osteopathic Manual Treatment for Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Osteopathic Manipulative Treatment
Hemiplegic Shoulder Pain

Treatments

Other: Osteopathic Manual Treatment
Other: Sham Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06098508
A536120 (Other Identifier)
SMPH/ORTHO&REHAB/REHAB MED (Other Identifier)
Protocol version 8/8/25 (Other Identifier)
2021-1051

Details and patient eligibility

About

This study assesses the feasibility and safety of performing osteopathic manual treatment (OMT) for hemiplegic shoulder pain in stroke patients. This study's participants will be adults with a first-time stroke diagnosis in the past 5 years and shoulder pain on the same side affected by stroke. Eligible participants will be placed on study for approximately 6 weeks and given either OMT or a sham treatment each week.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients must be at least 18 years or older to participate in the study
  • Presence of shoulder pain on the side of the body affected by stroke
  • Patients must have a diagnosis of a first-time stroke within the past 5 years
  • Stroke type must be subcortical, brainstem, and/or right-MCA stroke. Participants with multiple stroke types within the first-time diagnosis may be included

Exclusion criteria

  • Presence of an active systemic or localized infection requiring antibiotic therapy
  • Presence of fracture in the area being treated
  • Presence of open wound in the area being treated
  • Presence of rheumatoid arthritis
  • Presence of known active malignancy
  • Presence of shoulder pain on the affected side within 3 months prior to stroke
  • Patients with left-MCA stroke diagnosis who demonstrate the presence of aphasia based on the Mississippi Aphasia Screening Test (MAST)
  • Patients who demonstrate hemispatial visual neglect based on screening motor-free visual perception test (MFVPT)
  • Patients already receiving any type of manual therapy by a certified therapist through their standard-of-care treatment
  • Patients who do not wish to participate
  • Patients who are not fit as judged by the study team
  • Patients who lack the capacity to consent for enrollment in the study based on the University of California San Diego Brief Assessment of Capacity to Consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

3 participants in 2 patient groups

Osteopathic Manual Treatment
Experimental group
Treatment:
Other: Osteopathic Manual Treatment
Sham Treatment Arm
Sham Comparator group
Treatment:
Other: Sham Treatment

Trial contacts and locations

1

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Central trial contact

Ashley Mohan, DO; Caroline Jones

Data sourced from clinicaltrials.gov

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