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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopathic Manipulative Treatment; Hemiplegic Shoulder Pain
• Intervention / Treatment: Other: Osteopathic Manual Treatment; Other: Sham Treatment

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • UW Health University Ave Rehabilitation Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathic Manual Treatment	Other: Osteopathic Manual Treatment; 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 Comparator: Sham Treatment Arm	Other: Sham Treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Assessment	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.	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	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.	From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Ashley Mohan, DO, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: stroke; OMT; hemiplegic shoulder pain; Osteopathic Manual Treatment
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Pharmaceutical Preparations; Therapeutics; Placebos
• Other Study ID Numbers: 2021-1051; A536120 (Other Identifier: UW Madison); SMPH/ORTHO&REHAB/REHAB MED (Other Identifier: UW Madison); Protocol Version 8/8/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Preliminary data that has been anonymized may be shared within the academic intuition for research purposes. Once published, data will be shared with the general public. Any data that is published or presented will not be identifiable.

All data collected during the study will be banked indefinitely after study completion for future research. All participant identifiers will be removed prior to banking the data. The principal investigator and co-investigators of this current study will have access to the stored data. If there is a request for this data to be shared outside of this study team, the PI will decide if the data can be shared and the data will be fully anonymized. This data would be shared for future research related to osteopathic manual therapy.

• IPD Sharing Access Criteria: Researchers interested in pursuing OMT research may contact Ashley Mohan, DO, at mohan@rehab.wisc.edu for access to IPD documents.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No