Health Ford Health System
Detroit, Michigan, 48202, United States
Completed
NCT Number: NCT04503421
Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair
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
Completed
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Blood Flow Restriction Therapy
OtherUse of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
Primary outcomes
-
Strength
Time frame: 1 week post-operatively
measured via dynamometer (pounds)
-
Strength
Time frame: 6 weeks post-operatively
measured via dynamometer (pounds)
-
Strength
Time frame: 3 months post-operatively
measured via dynamometer (pounds)
-
Strength
Time frame: 6 months post-operatively
measured via dynamometer (pounds)
Secondary outcomes
-
Range of Motion
Time frame: 1 week post-operatively
via goniometer (degrees)
-
Range of Motion
Time frame: 6 week post-operatively
via goniometer (degrees)
-
Range of Motion
Time frame: 3 months post-operatively
via goniometer (degrees)
-
Range of Motion
Time frame: 6 months post-operatively
via goniometer (degrees)
-
Perceived Pain
Time frame: 1 week post-operatively
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
-
Perceived Pain
Time frame: 6 week post-operatively
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
-
Perceived Pain
Time frame: 3 months post-operatively
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
-
Perceived Pain
Time frame: 6 months post-operatively
via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
-
Patient reported outcome scores
Time frame: 1 week post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
-
Patient reported outcome scores
Time frame: 1 week post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
-
Patient reported outcome scores
Time frame: 1 week post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
-
Patient reported outcome scores
Time frame: 6 week post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
-
Patient reported outcome scores
Time frame: 6 week post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
-
Patient reported outcome scores
Time frame: 6 week post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
-
Patient reported outcome scores
Time frame: 3 months post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
-
Patient reported outcome scores
Time frame: 3 months post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
-
Patient reported outcome scores
Time frame: 3 months post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
-
Patient reported outcome scores
Time frame: 6 months post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score
-
Patient reported outcome scores
Time frame: 6 months post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score
-
Patient reported outcome scores
Time frame: 6 months post-operatively
via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Sponsors and collaborators
Lead sponsor
Henry Ford Health System
Other
Registry information
Official study title
Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial
Important dates
- Study start
- 2020
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Aug 7, 2020
- Registry last updated
- Dec 8, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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