Hemiplegic Shoulder PainNCT06098508
Osteopathic Manual Treatment for Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients
A study testing Osteopathic Manual Treatment in people with Hemiplegic Shoulder Pain and Osteopathic Manipulative Treatment, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegic Shoulder Pain, Osteopathic Manipulative Treatment
- What is being tested?
- Osteopathic Manual Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Health University Ave Rehabilitation Clinic
Middleton, Wisconsin, 53562
About this study
Official title: The Effects of Osteopathic Manual Treatment on Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients: A Pilot Study
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.
- Being tested
- Osteopathic Manual Treatment, Sham Treatment
- Keywords
- stroke, hemiplegic shoulder pain, Osteopathic Manual Treatment, OMT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manual TreatmentOther
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 TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manual Treatment | Experimental | Not described Receives: Other: Osteopathic Manual Treatment |
| Sham Treatment Arm | Sham comparator | Not described Receives: Other: Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (1)
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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start23 Jul 2024
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Mohan, DO, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098508
- Sponsor's protocol ID
- 2021-1051
- Other IDs
- SMPH/ORTHO&REHAB/REHAB MED, Protocol version 8/8/25, A536120
- Status last verified
- May 2025
- First submitted
- 18 Oct 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Osteopathic Manual Treatment on Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT06098508
- Acronym / sponsor ID
- 2021-1051
- Keywords
- stroke, hemiplegic shoulder pain, Osteopathic Manual Treatment, OMT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manual Treatment | Experimental | Other: Osteopathic Manual Treatment |
| Sham Treatment Arm | Sham comparator | Other: Sham Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manual TreatmentThis 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. | Other | Osteopathic Manual Treatment |
| Sham TreatmentThe 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. | Other | Sham Treatment Arm |
Primary outcome
Feasibility Assessment
Time frame: 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.
1 secondary outcome
Safety Assessment
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Yes. 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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Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Mohan, DO principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manual Treatment in people with Hemiplegic Shoulder Pain and Osteopathic Manipulative Treatment, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Assessment (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.