Hemiplegic Shoulder Pain, Osteopathic Manipulative Treatment
Conditions
Keywords
stroke, hemiplegic shoulder pain, Osteopathic Manual Treatment, OMT
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.
Interventions
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.
OTHERSham 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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed