Back to resultsOsteopathic Manual Treatment for Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients
Primary Purpose
Hemiplegic Shoulder Pain, Osteopathic Manipulative Treatment
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manual Treatment
Sham Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Shoulder Pain focused on measuring stroke, hemiplegic shoulder pain, Osteopathic Manual Treatment, OMT
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 year Stroke type must be right middle cerebral artery, brainstem, or subcortical ischemic stroke 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
Sites / Locations
- UW Health University Ave Rehabilitation Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Osteopathic Manual Treatment
Sham Treatment Arm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06098508
First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT06098508
Brief Title
Osteopathic Manual Treatment for Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients
Official Title
The Effects of Osteopathic Manual Treatment on Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Shoulder Pain, Osteopathic Manipulative Treatment
Keywords
stroke, hemiplegic shoulder pain, Osteopathic Manual Treatment, OMT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteopathic Manual Treatment
Arm Type
Experimental
Arm Title
Sham Treatment Arm
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Osteopathic Manual Treatment
Intervention Description
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
Intervention Name(s)
Sham Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility Assessment
Description
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.
Time Frame
From enrollment to the end of treatment at 6 weeks
Secondary Outcome Measure Information:
Title
Safety Assessment
Description
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.
Time Frame
From enrollment to the end of treatment at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 year
Stroke type must be right middle cerebral artery, brainstem, or subcortical ischemic stroke
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Mohan, DO
Phone
209-625-7064
Email
mohan@rehab.wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Janelle Suriaga
Phone
608-265-2413
Email
Suriaga@ortho.wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Mohan, DO
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW Health University Ave Rehabilitation Clinic
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Mohan, DO
Phone
608-263-6540
Email
mohan@rehab.wisc.edu
First Name & Middle Initial & Last Name & Degree
Ashley Mohan, DO
First Name & Middle Initial & Last Name & Degree
Sarah Gunderson, OT
First Name & Middle Initial & Last Name & Degree
Thomas Mehner, DO
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
Researchers interested in pursuing OMT research may contact Ashley Mohan, DO, at mohan@rehab.wisc.edu for access to IPD documents.
Learn more about this trial
Osteopathic Manual Treatment for Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients
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