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

Primary Purpose

Bicep Tendon Rupture

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Therapy
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bicep Tendon Rupture focused on measuring blood flow restriction, Rehabilitation, Physical therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Health Ford Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BFR

Control (no BFR)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Strength
measured via dynamometer (pounds)
Strength
measured via dynamometer (pounds)
Strength
measured via dynamometer (pounds)
Strength
measured via dynamometer (pounds)

Secondary Outcome Measures

Range of Motion
via goniometer (degrees)
Range of Motion
via goniometer (degrees)
Range of Motion
via goniometer (degrees)
Range of Motion
via goniometer (degrees)
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Perceived Pain
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Patient reported outcome scores
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score

Full Information

First Posted
July 28, 2020
Last Updated
February 10, 2021
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04503421
Brief Title
Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair
Official Title
Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bicep Tendon Rupture
Keywords
blood flow restriction, Rehabilitation, Physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BFR
Arm Type
Experimental
Arm Description
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
Arm Title
Control (no BFR)
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction Therapy
Intervention Description
Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
Primary Outcome Measure Information:
Title
Strength
Description
measured via dynamometer (pounds)
Time Frame
1 week post-operatively
Title
Strength
Description
measured via dynamometer (pounds)
Time Frame
6 weeks post-operatively
Title
Strength
Description
measured via dynamometer (pounds)
Time Frame
3 months post-operatively
Title
Strength
Description
measured via dynamometer (pounds)
Time Frame
6 months post-operatively
Secondary Outcome Measure Information:
Title
Range of Motion
Description
via goniometer (degrees)
Time Frame
1 week post-operatively
Title
Range of Motion
Description
via goniometer (degrees)
Time Frame
6 week post-operatively
Title
Range of Motion
Description
via goniometer (degrees)
Time Frame
3 months post-operatively
Title
Range of Motion
Description
via goniometer (degrees)
Time Frame
6 months post-operatively
Title
Perceived Pain
Description
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Time Frame
1 week post-operatively
Title
Perceived Pain
Description
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Time Frame
6 week post-operatively
Title
Perceived Pain
Description
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Time Frame
3 months post-operatively
Title
Perceived Pain
Description
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Time Frame
6 months post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Time Frame
1 week post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Time Frame
1 week post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Time Frame
1 week post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Time Frame
6 week post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Time Frame
6 week post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Time Frame
6 week post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Time Frame
3 months post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Time Frame
3 months post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Time Frame
3 months post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
Time Frame
6 months post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
Time Frame
6 months post-operatively
Title
Patient reported outcome scores
Description
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Time Frame
6 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Health Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toufic R Jildeh, MD
Phone
517-230-8511
Email
touficjildeh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18466185
Citation
Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.
Results Reference
background
PubMed Identifier
31592499
Citation
Huynh T, Leiter J, MacDonald PB, Dubberley J, Stranges G, Old J, Marsh J. Outcomes and Complications After Repair of Complete Distal Biceps Tendon Rupture with the Cortical Button Technique. JB JS Open Access. 2019 Aug 27;4(3):e0013.1-6. doi: 10.2106/JBJS.OA.19.00013. eCollection 2019 Jul-Sep.
Results Reference
background
PubMed Identifier
12635796
Citation
Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.
Results Reference
background
PubMed Identifier
11128848
Citation
Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.
Results Reference
background
PubMed Identifier
21917016
Citation
Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.
Results Reference
background

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

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