Blood Flow Restriction Training Versus Standard Physical Therapy After Shoulder Stabilization Surgery: A Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- shoulder Isometric strength
Study Overview
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.
Detailed Description
During study:
Participants will be recruited from the Keller Army Community Hospital (KACH) the KACH Orthopedic Clinic and the Arvin Cadet Physical Therapy Clinic. Participants will be screened for possible benefits of participation and related inclusion
/exclusion criteria as is done within traditional means by the referring provider.
Participant recruitment and briefing by the lead primary investigator (PI) or associate investigator (AI) will be conducted.
Participants wishing to participate in the study will undergo informed consent process with PI or AI. Participants agreeing to participate will complete consent by signing an informed consent form and HIPAA authorization form. All data will be recorded and stored by the subject identification number. Participants will be randomized into their assigned group of either receiving standard therapy with Blood Flow Restriction (BFR) or standard therapy alone 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 Blood Flow Restriction Training and/or 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. Baseline Testing All participants will undergo baseline testing at 6 weeks in the following order: 1.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 17 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
BFR group with standard therapy
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.
Intervention: Blood flow restriction therapy (Other)
BFR group with standard therapy
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.
Intervention: Standard Physical Thearapy (Other)
standard therapy group
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.
Intervention: Blood flow restriction therapy (Other)
Outcomes
Primary Outcomes
shoulder Isometric strength
Time Frame: 6 months
resisted isometric strength using dynamotor
shoulder function- (CKCUEST)
Time Frame: 6 months
Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST)
shoulder function- (UQYBT)
Time Frame: 6 months
Upper Quarter Y Balance Test (UQYBT)
shoulder function-(SSPT)
Time Frame: 6 months
Seated Shotput Test (SSPT)
shoulder Isometric strength
Time Frame: 6 weeks
resisted isometric strength using dynamotor
shoulder Isometric strength
Time Frame: 12 weeks
resisted isometric strength using dynamotor
Secondary Outcomes
- Quick Disabilities of Arm, Shoulder, Hand (QDASH)(6 months)
- Numerical Pain Rating Scale (NPRS)(6 months)
- Shoulder Pain and Disability Index (SPADI)(6 months)
- Single Assessment Numeric Evaluation (SANE)(6 months)
- ROM(6 months)
- Shoulder Pain and Disability Index (SPADI)(6 weeks)
- Shoulder Pain and Disability Index (SPADI)(12 weeks)
- Numerical Pain Rating Scale (NPRS)(12 weeks)
- Numerical Pain Rating Scale (NPRS)(6 weeks)
- Single Assessment Numeric Evaluation (SANE)(6 weeks,)
- Single Assessment Numeric Evaluation (SANE)(12 weeks)
- Quick Disabilities of Arm, Shoulder, Hand (QDASH)(6 weeks)
- Quick Disabilities of Arm, Shoulder, Hand (QDASH)(12 weeks)
- ROM(6 weeks)
- ROM(12 weeks)
Investigators
Jamie Morris
Director and Professor
Keller Army Community Hospital