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NCT Number: NCT06098508

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

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.

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Key information

Conditions

Hemiplegic Shoulder Pain Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Osteopathic Manipulative Treatment Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW Health University Ave Rehabilitation Clinic

Middleton, Wisconsin, 53562, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Osteopathic Manual Treatment

Other

This study will be using osteopathic manual therapy as the primary intervention. Osteopathic manual therapy (OMT) is a hands-on treatment that is performed by a specially trained physician known as a Doctor of Osteopathic Medicine (DO). This treatment can be used to diagnose and treat somatic dysfunctions, which are palpable areas of tightness, misalignment, and/or restricted motion within the musculoskeletal system and its related vascular and neural structures. A combination of myofascial release, strain/counterstain, soft tissue, balanced ligamentous release, facilitated positional release and muscle energy techniques will be used for the OMT treatment.

Sham Treatment

Other

The sham treatment will include a hands-on evaluation typically used to diagnose somatic dysfunctions, but no treatment will be performed. The sham treatment will assess the upper extremities/scapulae, ribs, cervical spine, thoracic spine, thoracic inlet, and occipital-atlantal regions.

Primary outcomes

  1. Feasibility Assessment

    Time frame: From enrollment to the end of treatment at 6 weeks

    The study team will assess feasibility by tracking participant recruitment, randomization, and retention. The ability to carry out the intervention protocol to completion in these participants will be assessed. Feasibility will be confirmed if 10 patients are randomized and at least 80% complete the study within the planned 1-year timeline.

Secondary outcomes

  1. Safety Assessment

    Time frame: From enrollment to the end of treatment at 6 weeks

    The study team will also assess the safety of performing osteopathic manual therapy in stroke patients with hemiplegic shoulder pain. Any reported adverse events (AE) and severe adverse events (SAE) will be tracked and monitored.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

The Effects of Osteopathic Manual Treatment on Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients: A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2023
Registry last updated
Dec 17, 2025

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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