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

Hemiplegic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098508
• Other study ID #: 2021-1051
• Secondary ID: SMPH/ORTHO&REHAB
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: University of Wisconsin, Madison
• Contact: Ashley Mohan, DO
• Phone: 608-263-6540
• Email: OMTStrokeProject[@]ortho.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, not including left-MCA, 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 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

Related Conditions & MeSH terms

• Hemiplegic Shoulder Pain
• Osteopathic Manipulative Treatment
• Shoulder Pain

Intervention

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 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.

Locations

Country	Name	City	State
United States	UW Health University Ave Rehabilitation Clinic	Middleton	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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