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

NCT06098508 | Completed

• 4 other identifiers: 2021-1051SMPH/ORTHO&REHAB/REHAB MEDProtocol version 8/8/25A536120
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegic Shoulder Pain; Osteopathic Manipulative Treatment

Keywords

stroke; hemiplegic shoulder pain; Osteopathic Manual Treatment; OMT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Assessment

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Osteopathic Manual Treatment

EXPERIMENTAL

Other: Osteopathic Manual Treatment

Sham Treatment Arm

SHAM COMPARATOR

Other: Sham Treatment

Interventions

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.

Osteopathic Manual 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.

Sham Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Health University Ave Rehabilitation Clinic

Middleton, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ashley Mohan, DO

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Other members of the study team, such as those who recruit, screen, and coordinate research visits, will be masked. Additionally, the occupational therapist who performs baseline pain ratings and arm function assessments will also be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: July 23, 2024
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Researchers interested in pursuing OMT research may contact Ashley Mohan, DO, at mohan@rehab.wisc.edu for access to IPD documents.

Locations

US (1)