BFR After Biceps Tendon Repair and MPFLR

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05375071

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy after distal biceps tendon repair or medial patellofemoral ligament reconstruction (MPFLR) following a tear.

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Joint Dislocation Bicep Tendon Rupture	Other: Blood Flow Restriction (BFR) Therapy Other: Physical Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Use of Blood Flow Restriction (BFR) Therapy in Peri-operative Rehabilitation Following Biceps Tendon Rupture and Medial Patellofemoral Ligament Reconstruction

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional rehabilitation plus blood flow restriction (BFR) therapy Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. Additionally, a BFR Cuff will be applied during physical therapy.	Other: Blood Flow Restriction (BFR) Therapy BFR Cuff will be applied to the most proximal portion of the affected arm or leg, immediately before performing exercises during physical therapy. The cuff will remain on for the entire time while an exercise is performed and will be removed in between exercises while the subject rests.
Active Comparator: Conventional rehabilitation Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.	Other: Physical Therapy Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests

Arm

Intervention/Treatment

Experimental: Conventional rehabilitation plus blood flow restriction (BFR) therapy

Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. Additionally, a BFR Cuff will be applied during physical therapy.

Other: Blood Flow Restriction (BFR) Therapy

BFR Cuff will be applied to the most proximal portion of the affected arm or leg, immediately before performing exercises during physical therapy. The cuff will remain on for the entire time while an exercise is performed and will be removed in between exercises while the subject rests.

Active Comparator: Conventional rehabilitation

Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.

Other: Physical Therapy

Standard of care physical therapy consisting of a structured program progressing from range of motion to strength training and then functional tests

Outcome Measures

Primary Outcome Measures

Change in strength [Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months]
Measured by a dynamometer

Secondary Outcome Measures

Change in range of motion [Post-operative 6 weeks, 12 weeks, 16 weeks, and 6 months]
Measured by a goniometer reported in degrees

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects will be recruited from our ambulatory sports medicine clinics. We will include patients aged 18-80 who suffered a biceps tear and are undergoing biceps repair or MPFLR

Exclusion Criteria:

Subjects will be excluded if they are undergoing revision biceps repair or revision MPFLR, history of DVT, neurovascular injury, unable to tolerate BFR treatment, unable to complete physical therapy, peripheral vascular disease
Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately. This will be facilitated by describing the reasons for withdrawal to the patient prior to initiating the study and ask patients and other providers to inform the investigators if there are any issues or concerns.