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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
36
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.
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.
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.
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).
University of Florida
Gainesville, Florida, United States
RECRUITINGRecruitment
Record the number of individuals a) approached, b) screened, c) qualified, and d) willing to participate. The reasons for participants who do not qualify or refuse to participate will be recorded.
Time frame: Monthly report from beginning to completion of recruitment (anticipated 2 years)
Intervention feasibility
The interventionist team will complete standardized notes of the intervention, which will be reviewed weekly to document adherence and protocol fidelity and for early identification of intervention deviations. Outcomes include the number of patients a) completing at least 80% of the assigned BFRT visits, b) requesting to stop BFRT within a session, c) requesting to withdraw from the intervention, and d) requesting to switch intervention arms. The last number is a proxy for patients who do not accept randomization results.
Time frame: Weekly record from enrollment to the end of treatment at 8 weeks.
Retention
Identify the number of dropouts and reasons impacting participation in follow-up visits.
Time frame: Weekly record from enrollment to 26 weeks (end of the trial).
Intervention safety
Monitor the occurrance of severe adverse events and exercise-related adverse events.
Time frame: Weekly record from enrollment to 26 weeks (end of the trial).
Participants masking feasibility
At the primary endpoint, participants will be asked to guess the treatment allocation to evaluate participant masking feasibility.
Time frame: At 8 weeks
Patient acceptability
A guided interview using Likert scale-type and open-ended questions will be conducted to gather participant feedback on trial and intervention procedures. An electronic copy of this questionnaire will be sent to patients who withdraw/stop showing up to understand whether trial or intervention procedures impact patient retention.
Time frame: At 8 weeks
Range of motion
The investigators will measure range of motion using an inclinometer or goniometer. The investigators will measure shoulder elevation in the scapular plane, external rotation, and internal rotation. The investigators will also measure coronal, axial, and sagittal rotation of the scapula during shoulder elevation in the scapular plane.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Strength
The investigators will measure shoulder elevation in the scapular plane and external rotation strength using a handheld dynamometer.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Timed Functional Arm and Shoulder Test (TFAST)
It includes three tasks: an internal/external rotation task (duration 30s), an outward circular motion task (duration 30s), and a gallon-lift task at the height of a standard counter (duration 30s). In each task, participants repeat movements as fast as possible.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Supraspinatus and infraspinatus muscle cross-sectional area
The investigators will use ultrasound to take pictures of the supraspinatus and infraspinatus muscles. This outcome represents a marker of hypertrophy, a potential mechanism of strengthening.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Supraspinatus tendon morphology
The investigators will use ultrasound to take pictures of the supraspinatus tendons. Established ultrasound procedures will be used to measure supraspinatus tendon thickness.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Supraspinatus tendon elastography
Ultrasound will be used to take pictures of the supraspinatus tendons. The investigators will set the ultrasound parameters to elastography, allowing non-invasive measurement of tendon stiffness and elasticity.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Pennsylvania Shoulder Score (PENN)
The PENN is a valid and reliable self-reported questionnaire for patients with shoulder pain.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
Global rating of change (GROC)
The GROC is a rating scale that quantifies participants' improvement or deterioration of symptoms over time. Changes will be measured using a 15-points Likert scale (-7, a very great deal worse to 7, a very great deal better, with 0 indicating no changes).
Time frame: At 4 weeks, 8 weeks and 6 months
Patient specific functional scale (PSFS)
The PSFS asks patients to rate their difficulty performing three activities of their choice. It is advantageous because it asks patients to select the activities rather than providing pre-selected options.
Time frame: From enrollment to 4 weeks, 8 weeks and 6 months
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