Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-13

Study Completion Date

2024-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Return to Baseball After BFR Therapy for Shoulder Injury

NCT04248413

Musculoskeletal Injury

WITHDRAWN NA

Blood Flow Restriction Training Following Glenoid Labral Repair

NCT03675620

Glenoid Labrum Tear

WITHDRAWN NA

Blood Flow Restriction in Post-surgery Rehabilitation of Latarjet Procedure

NCT06430567

Shoulder Dislocation

NOT_YET_RECRUITING NA

BFRT for Subacromial Pain

NCT06873113

Shoulder Pain

RECRUITING NA

Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?

NCT04596020

Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff Muscle Weakness

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Blood flow restriction (BFR) therapy is one such therapeutic tool that has received increasing attention, which involves application of a pressurized tourniquet to the injured limb during rehabilitation that limits atrophy when performing strength training with weight that otherwise would not produce enough of a contraction to prevent muscular atrophy. To date, several studies have been performed on BFR therapy, however, the effect of therapy on ligamentous and tendinous injury in the upper extremity remain unclear as most studies have focused on muscular strengthening in healthy individuals and on lower extremity injuries distal to the tourniquet.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients who will be recruited into randomized into 1 of 2 study arms: 1) those undergoing rehabilitation using Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol or 2) those undergoing rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blood Flow Restriction (BFR)

Blood Flow Restriction (BFR) pressurized per standard protocols in addition to our institutional rehabilitation protocol

Group Type EXPERIMENTAL

Blood Flow Restriction

Intervention Type DEVICE

In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.

"sham" Blood Flow Restriction (BFR)

rehabilitation using "sham BFR" as well as our institutional rehabilitation protocol

Group Type SHAM_COMPARATOR

"sham" Blood Flow Restriction

Intervention Type DEVICE

In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood Flow Restriction

In the BFR group, the tourniquet will be pressurized to 50% limb occlusion pressure (LOP), which is the pressure necessary for occluding 50% of arterial limb flow in the upper extremity.

Intervention Type DEVICE

"sham" Blood Flow Restriction

In the sham BFR group, the tourniquet will be pressurized to 0% occlusion pressure, while maintaining enough pressure to keep the tourniquet in place.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BFR

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy
* no prior upper extremity ipsilateral procedures or history of deep vein thrombosis
* those willing to be part of the study

Exclusion Criteria

* patients younger than 18 or older than 55 years of age
* a history of revision surgery or prior ipsilateral upper extremity surgery
* concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol
* inability to comply with the proposed follow-up clinic visits
* patients lacking decisional capacity

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No