BFRT for Subacromial Pain

Study Purpose

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).

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 - 50 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

- 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

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.	NCT06873113
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 Florida
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Shoulder Pain

Arms & Interventions

Arms

Experimental: Active BFRT

Sham Comparator: Sham BFRT

Interventions

Device: - Active BFRT

The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains 50% of participants limb occlusion pressure for the duration of each strengthening exercise.

Device: - Sham BFRT

The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains a pressure of 20mmHg for the duration of each strengthening exercise.

Behavioral: - Strengthening Exercises with BFRT

Participants perform 4 strengthening exercises while using the BFR device: seated scapular plane elevation, prone horizontal abduction, side-lying external rotation, and prone scapular plane elevation. Each exercise is performed unilaterally. Participants perform 1 set of 30 repetitions followed by 3 sets of 15 repetitions (4 total sets, 75 total repetitions). Participants are given 30 seconds rest between sets and 2 minutes of rest between strengthening exercises. Selected resistance for each strengthening exercise is equal to 20% of the participant's maximal force production as measured by handheld dynamometry. Resistance is adjusted weekly.

Behavioral: - Skilled Physical Therapy Care

Participants perform non-strengthening interventions as part of skilled physical therapy care. Non-strengthening interventions include an upper arm ergometer for warm-up, active assisted range of motion of the shoulder, shoulder stretching, shoulder joint mobilizations, and cryotherapy. Non-strengthening interventions are prescribed at the discretion of the treating physical therapist. Participants are enrolled in physical therapy for a minimum of 4 weeks. After 4 weeks, the treating physical therapist can discharge a participant based on their progress in meeting their rehabilitation goals. Participants discharged from skilled physical therapy care will continue to complete strengthening exercises with BFRT until the end of the trial period (8 weeks).

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.

University of Florida, Gainesville, Florida

Status

Address

University of Florida

Gainesville, Florida, 32610

Site Contact

Shea Herlihy, MS

[email protected]

352-273-7361

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