Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair

Study Overview
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Brief Summary
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The goal of this investigation is to determine if using BFR during postoperative therapy would lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. The study will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding distal biceps tear and surgical repair

Official Title
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Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial

Conditions
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Bicep Tendon Rupture

Intervention / Treatment
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* Other: Blood Flow Restriction Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 Undergoing distal biceps tendon repair Exclusion Criteria: Revision Biceps tendon repair, Irrepairable tendon injury, Biceps repairs with biologic augmentation, Patients with concomitant neurovascular injury, Inability to tolerate BFR treatment, Unable to complete full course of physical therapy, Peripheral vascular disease, History of Venous thromboembolism (VTE)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFR<br>Patient will use the following rehabilitation protocol while incorporating blood flow restriction therapy: Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only Sling immobilization with active wrist and shoulder ROM Active extension of biceps to 30 degrees, No active flexion 6-9 weeks full active extension in brace Maintain wrist and shoulder flexibility Begin rotator cuff/deltoid isometrics, progress active extension in brace Weeks 9-12: Gently advance ROM to tolerance Discontinue sling Begin active flexion and extension against gravity. Advance strength to light resistance, maintain flexibility/ROM Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated | Other: Blood Flow Restriction Therapy<br>* Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy<br>|
| No Intervention: Control (no BFR)<br>patients will use following rehabilitation protocol without the use of blood flow restriction therapy: Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only Sling immobilization with active wrist and shoulder ROM Active extension of biceps to 30 degrees, No active flexion 6-9 weeks full active extension in brace Maintain wrist and shoulder flexibility Begin rotator cuff/deltoid isometrics, progress active extension in brace Weeks 9-12: Gently advance ROM to tolerance Discontinue sling Begin active flexion and extension against gravity. Advance strength to light resistance, maintain flexibility/ROM Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength | measured via dynamometer (pounds) | 1 week post-operatively | 
| Strength | measured via dynamometer (pounds) | 6 weeks post-operatively | 
| Strength | measured via dynamometer (pounds) | 3 months post-operatively | 
| Strength | measured via dynamometer (pounds) | 6 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | via goniometer (degrees) | 1 week post-operatively | 
| Range of Motion | via goniometer (degrees) | 6 week post-operatively | 
| Range of Motion | via goniometer (degrees) | 3 months post-operatively | 
| Range of Motion | via goniometer (degrees) | 6 months post-operatively | 
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 1 week post-operatively | 
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 6 week post-operatively | 
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 3 months post-operatively | 
| Perceived Pain | via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain) | 6 months post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 1 week post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 1 week post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 1 week post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 6 week post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 6 week post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 6 week post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 3 months post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 3 months post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 3 months post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score | 6 months post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score | 6 months post-operatively | 
| Patient reported outcome scores | via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score | 6 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood flow restriction, Rehabilitation, Physical therapy