Blood Flow Restriction Training Versus Standard Physical Therapy After Shoulder Stabilization Surgery

NCT05506072 | Completed

• 2 other identifiers: KACH.2022.005822KACH005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses: The purpose of this Randomized Controlled Trial is to evaluate the effectiveness of Blood Flow Restriction (BFR) training with standard care of physical therapy versus the standard care of Physical Therapy alone and its effect on shoulder function and patient outcomes in military cadets recovering from shoulder stabilization surgery. We hypothesize after 6 weeks of BFR training will contribute to 13 (76%) or more participants will achieve scores within one standard deviation of normative values for isometric strength and functional tests at six months following shoulder stabilization surgery. Furthermore, we hypothesize that 14 (82%) or more participants will report improved patientreported outcomes as determined by the minimal clinical difference (MCD) at 12 weeks and six months post-operatively. Objective 1: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder isometric strength, as measured by a digital handheld dynamotor following shoulder stabilization surgery in military cadets. Objective 2: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder range of motion, as measured by a digital inclinometer, following shoulder stabilization surgery in military cadets. Objective 3: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder function as measured by the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), Seated Shot-Put Test (SSPT), and Upper Quarter Y-Balance Test (UQYBT), following shoulder stabilization surgery in military cadets. Objective 4: To evaluate the effectiveness of BFR training on shoulder pain, measured by a numerical pain rating scale, following shoulder stabilization surgery in military cadets. Objective 5: To evaluate the effectiveness of a BFR training on patient-reported outcomes, measured by Single Assessment Numeric Evaluation (SANE), Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder and Hand (DASH) following shoulder stabilization surgery in military cadets. Aim 1:To identify whether BFR with Physical Therapy is more effective at increasing shoulder strength than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder strength than the Physical Therapy group without BFR following shoulder stabilization surgery. Aim 2:To identify whether BFR with Physical Therapy is more effective at increasing shoulder function than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder function than the Physical Therapy group without BFR following shoulder stabilization surgery.

Conditions

Anterior Shoulder Dislocation; Recurrent Shoulder Dislocation; Shoulder Subluxation; Surgery

Outcome Measures

Primary Outcomes (6)

• shoulder Isometric strength

  resisted isometric strength using dynamotor

  6 weeks

• shoulder Isometric strength

  resisted isometric strength using dynamotor

  12 weeks

• shoulder Isometric strength

  resisted isometric strength using dynamotor

  6 months

• shoulder function- (CKCUEST)

  Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST)

  6 months

• shoulder function- (UQYBT)

  Upper Quarter Y Balance Test (UQYBT)

  6 months

• shoulder function-(SSPT)

  Seated Shotput Test (SSPT)

  6 months

Secondary Outcomes (15)

• Numerical Pain Rating Scale (NPRS)

  6 weeks

• Numerical Pain Rating Scale (NPRS)

  12 weeks

• Numerical Pain Rating Scale (NPRS)

  6 months

• Shoulder Pain and Disability Index (SPADI)

  6 weeks

• Shoulder Pain and Disability Index (SPADI)

  12 weeks

Study Arms (2)

BFR group with standard therapy

EXPERIMENTAL

Participants will be randomized into their assigned group of receiving standard therapy with BFR by a blinded therapist within the study. Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of Blood Flow Restriction Training with the standard rehabilitation exercises. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training.

Other: Blood flow restriction therapy; Other: Standard Physical Thearapy

standard therapy group

ACTIVE COMPARATOR

Participants will be randomized into their assigned group of receiving standard therapy without BFR by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of standard rehabilitation exercises without BFR. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training.

Other: Blood flow restriction therapy

Interventions

Blood flow restriction therapy OTHER

Blood Flow Restriction involves the application of a tourniquet to an extremity to partially restrict the arterial and venous blood flow to stimulate localized cellular and systemic hormonal changes that occur in high intensity exercise. BFR Training may produce similar cellular and muscular responses to cause hypertrophy when exercise is performed at low intensity. Studies have compared BFR therapy in the lower extremities with light load resistance exercise to light load resistance alone and observed greater improvements in the BFR group. A recent systematic review further identified that adding BFR to exercise effectively augments muscle strength and size. Additionally, BFR has been shown to be applied in a safe manner with low risk for complications. With this growing body of evidence supporting BFR, it is becoming increasingly common in rehabilitation

BFR group with standard therapy; standard therapy group

Standard Physical Thearapy OTHER

Participants will be randomized into their assigned group of receiving standard therapy without BFR by a blinded therapist within the study using a computer generated randomization formula Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six months after their surgery. During each of these visits, they will be asked to complete a survey, and then their shoulder strength and flexibility will be measured. Each study visit will last approximately 30 minutes. Participants will also attend 12-18 shoulder rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about two to three sessions per week). Each rehabilitation session will last approximately 30 minutes and consist of standard rehabilitation exercises without BFR. Between the 12-week follow-up and 6-month follow-up, participants will receive standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow Restriction training.

BFR group with standard therapy

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• enrolled in the US Military Academy as a Cadet?
• between the age of 17 to 30 years?
• USMA cadet who was diagnosed with unilateral or multi-directional instability who underwent primary or revised surgery as well as open and arthroscopic shoulder stabilization surgery procedures at KACH.
• near 6 weeks post-operative at start and will be cleared to begin strengthening exercises at that time

You may not qualify if:

• Have not had a rotator cuff surgery with the current surgical repair?
• Have not had a humeral neck or shaft fracture?
• Had not had a history of head, neck, or shoulder procedures requiring general anesthesia within 6 weeks from surgery
• Have not had a history of deep vein thrombosis (DVT) within the 12 months from your surgical date
• Not currently pregnant
• Don't have a history of upper quadrant lymph node dissection, endothelial dysfunction
• Don't have an active infection or are you currently diagnosed and fighting cancer
• Don't bruise easily and/or have a bleeding disorder

Sponsors & Collaborators

• Keller Army Community Hospital: lead

Study Sites (1)

Keller Army Community Hospital - ARVIN

West Point, New York, 10996, United States

Location

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 18, 2022
• Study Start: June 23, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)