Trial Outcomes & Findings for BFR Therapy in Patients With Rotator Cuff Tears (NCT NCT04384120)
NCT ID: NCT04384120
Last Updated: 2025-06-05
Results Overview
Strength will be quantified through dynamometers
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
through study completion, an average of 12 months post-operative follow-up
Results posted on
2025-06-05
Participant Flow
Participant milestones
| Measure |
Rotator Cuff Rehabilitation Using BFR
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.
Blood Flow Restriction Therapy: Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.
|
Rotator Cuff Rehabilitation Without BFR
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.
Traditional Therapy: Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Rotator Cuff Rehabilitation Using BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.
Blood Flow Restriction Therapy: Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.
|
Rotator Cuff Rehabilitation Without BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.
Traditional Therapy: Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 10 • n=15 Participants
|
55.9 years
STANDARD_DEVIATION 6 • n=15 Participants
|
58.2 years
STANDARD_DEVIATION 9 • n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
8 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
22 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Strength
|
7.34 Pounds
STANDARD_DEVIATION 4.14 • n=15 Participants
|
7.24 Pounds
STANDARD_DEVIATION 4.14 • n=15 Participants
|
7.3 Pounds
STANDARD_DEVIATION 3.23 • n=30 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 12 months post-operative follow-upStrength will be quantified through dynamometers
Outcome measures
| Measure |
Rotator Cuff Rehabilitation Using BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.
Blood Flow Restriction Therapy: Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.
|
Rotator Cuff Rehabilitation Without BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.
Traditional Therapy: Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.
|
|---|---|---|
|
Strength
|
7.39 Pounds
Standard Deviation 3.93
|
6.05 Pounds
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: through study completion, an average of 12 months post-operative follow-upRange of motion of the shoulder will be assessed using a goniometer
Outcome measures
| Measure |
Rotator Cuff Rehabilitation Using BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.
Blood Flow Restriction Therapy: Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.
|
Rotator Cuff Rehabilitation Without BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.
Traditional Therapy: Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.
|
|---|---|---|
|
Range of Motion
|
82.4 degrees
Standard Deviation 24.7
|
65.1 degrees
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: through study completion, an average of 12 months post-operative follow-upPain will be assessed using a visual analogue scale (VAS), a pain scale from 0-10 where higher numbers indicate worse pain
Outcome measures
| Measure |
Rotator Cuff Rehabilitation Using BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.
Blood Flow Restriction Therapy: Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.
|
Rotator Cuff Rehabilitation Without BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.
Traditional Therapy: Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.
|
|---|---|---|
|
Pain Score
|
30.3 points
Standard Deviation 4.7
|
26.3 points
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: through study completion, an average of 12 months post-operative follow-upPatient reported outcome measurement information system (PROMIS) scores will be collected through a series of questionnaires from the PROMIS domain of physical function, upper extremity, and depression. These scores are standardized T-scores with the mean set at 50 and the standard deviation set at 10. PROMIS scores for Physical function, the higher the score the better. PROMIS score for depression, the lower the score the better. PROMIS score for Upper extremity, the higher the score the better.
Outcome measures
| Measure |
Rotator Cuff Rehabilitation Using BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.
Blood Flow Restriction Therapy: Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.
|
Rotator Cuff Rehabilitation Without BFR
n=15 Participants
Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs.
1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs.
2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.
Traditional Therapy: Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System
PROMIS-D
|
47 points
Standard Deviation 9.8
|
47 points
Standard Deviation 9.4
|
|
Patient Reported Outcomes Measurement Information System
PROMIS-PI
|
63 points
Standard Deviation 8.8
|
63 points
Standard Deviation 6.7
|
|
Patient Reported Outcomes Measurement Information System
PROMIS-UE
|
30.3 points
Standard Deviation 4.7
|
26.3 points
Standard Deviation 6.3
|
Adverse Events
Rotator Cuff Rehabilitation Using BFR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rotator Cuff Rehabilitation Without BFR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place