Return to Baseball After BFR Therapy for Shoulder Injury

NCT04248413 | Withdrawn FDA Device

• 1 other identifier: IRB00062859
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The literature is limited on whether BFR therapy provides improved return to function after acute rotator cuff or biceps rehabilitation in non-operative cases, and whether there is a clear mechanism of action in musculotendinous repair after BFR therapy. The purpose of the study is to 1) evaluate patient reported outcomes and return to play in baseball athletes undergoing rehabilitation with blood flow restriction (BFR) therapy for shoulder injury and 2) evaluate changes in blood biomarkers to assess the mechanism of action of BFR therapy in injured athletes. Investigators will perform a randomized blinded placebo-controlled trial of 2 separate study populations: 1) baseball players with biceps or rotator cuff tendinopathy undergoing non-operative treatment with BFR therapy incorporated into routine physical rehabilitation and 2) baseball players with biceps or rotator cuff tendinopathy undergoing non-operative treatment with routine physical rehabilitation alone. Primary outcomes will be functional outcomes and evaluation of return to sport. Functional outcomes will be evaluated using validated patient reported outcome surveys that are upper extremity-specific. Return to sport will be assessed by evaluating time to receiving clearance for returning to routine practices and reported level of physical performance and re-injury. Secondary outcomes will be measurement in muscle strength and blood biomarkers, as well as evaluation of 3D throwing motion. Strength will be measured using a biodex system at baseline prior to beginning physical rehabilitation, half-way through the rehabilitation protocol +/- BFR phase, and once cleared for return to play. Blood biomarkers GH, IGF-I, and IL-6 will be quantified at the same time points in order to investigate the mechanism of action of BFR on tissue repair. Patients will be followed longitudinally during this time for rates of reinjury.

Conditions

Musculoskeletal Injury

Keywords

Shoulder injury; Baseball injury; Muscle strength

Outcome Measures

Primary Outcomes (12)

• American Shoulder and Elbow Surgeons (ASES) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.

  Questionnaire assigned at baseline prior to the rehabilitation protocol.

• American Shoulder and Elbow Surgeons (ASES) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.

  Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.

• American Shoulder and Elbow Surgeons (ASES) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.

  Questionnaire assigned at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.

• American Shoulder and Elbow Surgeons (ASES) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.

  Questionnaire assigned 6-months after completing the rehabilitation protocol.

• American Shoulder and Elbow Surgeons (ASES) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A higher score denotes a better outcome.

  Questionnaire assigned 12-months after completing the rehabilitation protocol.

• Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.

  Questionnaire assigned at baseline prior to the rehabilitation protocol.

• Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.

  Questionnaire assigned at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.

• Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.

  Questionnaire assigned at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.

• Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.

  Questionnaire assigned 6-months after completing the rehabilitation protocol.

• Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

  Patient-reported outcome questionnaire with a score ranging from 0 to 100. A lower score denotes a better outcome.

  Questionnaire assigned 12-months after completing the rehabilitation protocol.

• Return to sport questionnaire

  Patient-reported questionnaire evaluating physical performance and re-injury after undergoing rehabilitation. Patient-reported outcome questionnaire with a score ranging from 0 to 10. A higher score denotes a better outcome.

  Questionnaire assigned 6-months after completing the rehabilitation protocol.

• Return to sport questionnaire

  Patient-reported questionnaire evaluating physical performance and re-injury after undergoing rehabilitation. Patient-reported outcome questionnaire with a score ranging from 0 to 10. A higher score denotes a better outcome.

  Questionnaire assigned 12-months after completing the rehabilitation protocol.

Secondary Outcomes (14)

• Muscle Strength

  Measured at baseline prior to the rehabilitation protocol.

• Muscle Strength

  Measured at the half-way point during the rehabilitation protocol, which is approximately 6-7 weeks from start of rehabilitation.

• Muscle Strength

  Measured at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.

• 3D throwing motion analysis

  Performed at baseline prior to the rehabilitation protocol.

• 3D throwing motion analysis

  Performed at the end of the rehabilitation protocol, corresponding to when the patient is cleared to return to sport, which is approximately 12-14 weeks from start of rehabilitation.

Study Arms (2)

Standard rehabilitation protocol

OTHER

Patients with non-operative rotator cuff and biceps tendinopathy assigned to this study arm will undergo the standardized physical rehabilitation protocol at our institution.

Other: Standard physical rehabilitation

Standard rehabilitation plus Blood Flow Restriction Therapy

EXPERIMENTAL

Patients with non-operative rotator cuff and biceps tendinopathy assigned to this study arm will undergo the standardized physical rehabilitation protocol at our institution in addition to the BFR therapy. Per recommendations of Owens Recovery Science, the organization responsible for certifying physical therapists in BFR therapy, the therapy will take place concurrently throughout the duration of the rehabilitation.

Device: Blood Flow Restriction Therapy; Other: Standard physical rehabilitation

Interventions

Blood Flow Restriction Therapy DEVICE

The blood flow restriction cuff, which is regulated by the FDA under 878.5910 and is registered under number 9681444, is manufactured by Delfi Medical. The cuff will be used as recommended by the manufacturer and Owens Recovery Science, the company who provides certificating of blood flow restriction training.

Standard rehabilitation plus Blood Flow Restriction Therapy

Standard physical rehabilitation OTHER

Patients diagnosed with non-operative rotator cuff or biceps tendinopathy will undergo physical rehabilitation under the supervision of the same physical therapists who will be performing the BFR therapy.

Standard rehabilitation plus Blood Flow Restriction Therapy; Standard rehabilitation protocol

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• any injured baseball athletes ages 14 to 25 years with clinical and radiographic examination (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

You may not qualify if:

• patients younger than 14 or older than 25 years of age
• non-native English speakers
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

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MeSH Terms

Conditions

Shoulder Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kristen F Nicholson, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The PI who will be performing the analysis will be blinded to patients who underwent routine physical rehabilitation vs those who underwent routine rehabilitation plus blood flow restriction therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The purpose of the study is to 1) evaluate patient reported outcomes and return to play in baseball athletes undergoing rehabilitation with blood flow restriction (BFR) therapy for shoulder injury and 2) evaluate changes in blood biomarkers to assess the mechanism of action of BFR therapy in injured athletes.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: May 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share