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

NCT ID: NCT06098508

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-23
• Study Completion Date: 2025-11-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Osteopathic Manual Treatment

Group Type: EXPERIMENTAL

Osteopathic Manual Treatment

Intervention Type: 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 Arm

Group Type: SHAM_COMPARATOR

Sham Treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley Mohan, DO

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

UW Health University Ave Rehabilitation Clinic

Middleton, Wisconsin, United States

Countries

United States

Other Identifiers

2021-1051

Identifier Type: -

Identifier Source: org_study_id

SMPH/ORTHO&REHAB/REHAB MED

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol version 8/8/25

Identifier Type: OTHER

Identifier Source: secondary_id

A536120

Identifier Type: OTHER

Identifier Source: secondary_id