Clinical Trial Finder

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06098508
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Wisconsin, Madison
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ashley Mohan, DO
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hemiplegic Shoulder Pain, Osteopathic Manipulative Treatment
Arms & Interventions

Arms

Experimental: Osteopathic Manual Treatment

Sham Comparator: Sham Treatment Arm

Interventions

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.

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Middleton, Wisconsin

Status

Recruiting

Address

UW Health University Ave Rehabilitation Clinic

Middleton, Wisconsin, 53562

Site Contact

Ashley Mohan, DO

[email protected]

608-263-6540

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