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

Not Applicable

Recruiting

• Conditions: Osteopathic Manipulative Treatment; Hemiplegic Shoulder Pain
• Interventions: Other: Osteopathic Manual Treatment; Other: Sham Treatment

• Registration Number: NCT06098508
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Study Start: 2024-07-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteopathic Manual Treatment	Osteopathic Manual Treatment	-
Sham Treatment Arm	Sham Treatment	-

Primary Outcome Measures

Name	Time	Method
Feasibility Assessment	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 Outcome Measures

Name	Time	Method
Safety Assessment	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.

Trial Locations

Locations (1)

UW Health University Ave Rehabilitation Clinic; 🇺🇸 Middleton, Wisconsin, United States