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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/ORTHO&REHAB/REHAB MED | Other Identifier | UW Madison | |
| Protocol version 8/8/25 | Other Identifier | UW Madison | |
| A536120 | Other Identifier | UW Madison |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathic Manual Treatment | Experimental |
| |
| Sham Treatment Arm | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Mohan, DO | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health University Ave Rehabilitation Clinic | Middleton | Wisconsin | 53562 | United States |
Preliminary data that has been anonymized may be shared within the academic intuition for research purposes. Once published, data will be shared with the general public. Any data that is published or presented will not be identifiable.
All data collected during the study will be banked indefinitely after study completion for future research. All participant identifiers will be removed prior to banking the data. The principal investigator and co-investigators of this current study will have access to the stored data. If there is a request for this data to be shared outside of this study team, the PI will decide if the data can be shared and the data will be fully anonymized. This data would be shared for future research related to osteopathic manual therapy.
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Researchers interested in pursuing OMT research may contact Ashley Mohan, DO, at mohan@rehab.wisc.edu for access to IPD documents.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| 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. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |