Subacromial Impingement Syndrome, Partial Thickness Rotator Cuff Tear
Conditions
Keywords
subacromial impingement, partial thickness rotator cuff, PRP, platelet rich plasma
Brief summary
The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions. Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment. Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed. Subjects will be between 18 and 89 years of age. In total, subject participation will last approximately 3 months.
Interventions
BIOLOGICALplatelet rich plasma injection
45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions.
DRUGcorticosteroid injection
Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Patients presenting with rotator cuff symptoms for at least 4 weeks 2. Examination reveals diffuse pain with provocative maneuvers 3. Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear) 4. Willingness to participate in an investigational technique 5. Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)
Exclusion criteria
1. Previous rotator cuff repair 2. Complete rotator cuff tear or two tendon tears 3. Pt w/ complex regional pain syndrome 4. Cervical neuropathy or other nerve pathology 5. RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy 6. Evidence of intraarticular arthritis 7. Work related or compensable injury 8. Previous treatment: corticosteroid injection in the last 6 months 9. Patients who are currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain and Disability of the Shoulder Through Validated Questionnaires | 6 weeks from initial injection of corticosteroid versus platelet rich plasma | Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control corticosteroid injection into subacromial space
corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions. | 5 |
| Experimental patients will receive an injection of platelet rich plasma into the subacromial space
platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions. | 7 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Experimental | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 59.3 years STANDARD_DEVIATION 14.7 | 59.2 years STANDARD_DEVIATION 6.4 | 59.25 years STANDARD_DEVIATION 11.54 |
| Region of Enrollment United States | 7 participants | 5 participants | 12 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 |
Outcome results
Primary
Pain and Disability of the Shoulder Through Validated Questionnaires
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Time frame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain and Disability of the Shoulder Through Validated Questionnaires | 81.6 units on a scale | Standard Deviation 9.4 |
| Experimental | Pain and Disability of the Shoulder Through Validated Questionnaires | 70.0 units on a scale | Standard Deviation 13.7 |
Primary
Pain and Disability of the Shoulder Through Validated Questionnaires
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Time frame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain and Disability of the Shoulder Through Validated Questionnaires | 41.6 units on a scale | Standard Deviation 4.7 |
| Experimental | Pain and Disability of the Shoulder Through Validated Questionnaires | 86.1 units on a scale | Standard Deviation 17.1 |
Primary
Pain and Disability of the Shoulder Through Validated Questionnaires
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
Time frame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain and Disability of the Shoulder Through Validated Questionnaires | 35.0 units on a scale | Standard Deviation 18.9 |
| Experimental | Pain and Disability of the Shoulder Through Validated Questionnaires | 43.9 units on a scale | Standard Deviation 7.4 |