BFRT for Subacromial Pain
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StatusAccepting Candidates
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Age18 Years - 50 Years
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SexesAll
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Healthy VolunteersNo
Objective
The goal of this pilot clinical trial is to learn if blood flow restriction training is safe and feasible in patients with subacromial pain. The main questions the investigators
Aim to answer are:
What problems do participants with shoulder pain encounter when training with blood flow restriction?
Is it feasible to apply blood flow restriction training as part of a physical therapy intervention?
What are some preliminary effects of blood flow restriction training on the recovery of shoulder function and strength?
The investigators will compare active blood flow restriction training to sham (an inactive procedure designed to mimic the active training as closely as possible).
Participants will:
Visit the clinic for physical therapy visits and exercise with blood flow restriction training for up to 8 weeks
Visit the clinic for tests before starting the treatment, during the treatment (4 weeks), and after the end of the treatment (8 and 26 weeks).
Details
| Full study title | Blood flow restriction training for patients with subacromial pain: a pilot randomized trial |
| Protocol number | OCR45429 |
| ClinicalTrials.gov ID | NCT06873113 |
| Phase | N/A |
Eligibility
Inclusion criteria
Between 18 and 50 years of age
Unilateral pain in the anterolateral shoulder
Self-reported shoulder function of ≤7 (10, full function)
At least 90° of active shoulder elevation
3 out of 5 positive tests to define subacromial pain.
Exclusion Criteria (general):
history of shoulder fracture, frozen shoulder, or shoulder surgery
primary complaint of shoulder instability/dislocation
history of cardiovascular, neurologic, and pulmonary conditions that would impair the subject's ability to participate in physical therapy
active treatment for cancer
uncontrolled diabetes
uncontrolled high blood pressure
corticosteroid injection at the shoulder within 6 weeks
imaging evidence of rotator cuff tears
pregnancy
Exclusion criteria (Blood flow restriction training specific)
contraindications to BFRT (sickle cell anemia, deep vein thrombosis, peripheral circulatory diseases)
taking anticoagulant or antiplatelet drugs
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
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Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.