Partial Tear of Rotator Cuff, Tendinopathy of Rotator Cuff
Conditions
Brief summary
The goal of this project is to identify an effective and conservative approach to treating partial thickness rotator cuff tears (PTRCT) that otherwise would end with a surgical correction needed.
Detailed description
Based off literature and clinical practice, the majority of rotator cuff tears continue to progress to surgical correction despite conservative measures. These include physical therapy, medication management and minimally invasive procedures such as subacromial bursa injections and intra-articular injections with steroids. Recently a popular treatment of common musculoskeletal injuries (including tendinopathies) has emerged throughout the US and has been utilized worldwide for many years with good empiric evidence known as Platelet-Rich Plasma (PRP) injections. In partnership with UAB Orthopedics and Radiology, the UAB Department of Physical Medicine and Rehabilitation aims to compare PRP to corticosteroid injections for patients with partial rotator cuff tears or tendinopathy. Outcome measures are ultrasound imaging, pain and disability over the course of 6 months.
Interventions
PROCEDUREPRP injection into PTRCT
Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury. PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
DRUGSubacromial steroid bursal injection
Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. subjects between ages 19 to 75, both male and female 2. radiologic imaging which can include either magnetic resonance imaging (MRI) or ultrasound (US) consistent with partial thickness rotator cuff tears of any degree except for full thickness tears 3. Failed a trial of physical therapy of at least 4 weeks
Exclusion criteria
1. Full thickness tears (well documented need for surgical correction) 2. sensory or neurologic complaint affecting the shoulder of interest 3. Coagulation disorder, platelet disorder 4. Pregnancy: Pregnancy test will be performed on women of childbearing age prior to their participation in the interventional portion of the study 5. Any major systemic illness such as ongoing infection or any condition that requires strict anti-platelet or anticoagulation therapy 6. Prior surgery to either cervical spine or shoulder 7. Active military 8. Injury part of worker compensation claim
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Ultrasound | 6 months post procedure | Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain and Disability Index | Week 3 post procedure SPADI Scores for the control and treatment groups. | Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from an outpatient Physical Medicine and Rehabilitation clinic at the University of Alabama. Each subject was given information regarding the study requirements and follow up obligations prior to enrollment and signed to complete based on their confidentiality agreement form.
Pre-assignment details
Three subjects in this study were enrolled however prior to randomization in to their respective groups, they had a negative diagnostic ultrasound thus they were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| PRP Injection Into PTRCT Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug. | 5 |
| Subacromial Steroid Bursal Injection Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound | 2 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 0 |
Baseline characteristics
| Characteristic | Subacromial Steroid Bursal Injection | Total | PRP Injection Into PTRCT |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 7 Participants | 5 Participants |
| Age, Continuous | 57.5 Years | 50 Years | 48.13 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 11 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
| SPADI (Shoulder Pain and Disability Index) Score | 23.08 SPADI Score | 37.80 SPADI Score | 43.69 SPADI Score |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 2 |
| other Total, other adverse events | 0 / 9 | 0 / 2 |
| serious Total, serious adverse events | 0 / 9 | 0 / 2 |
Outcome results
Primary
Diagnostic Ultrasound
Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.
Time frame: 6 months post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRP Injection Into PTRCT | Diagnostic Ultrasound | Incomplete data (lost to follow up) | 1 Participants |
| PRP Injection Into PTRCT | Diagnostic Ultrasound | Number with improved (smaller) tear at follow up | 2 Participants |
| PRP Injection Into PTRCT | Diagnostic Ultrasound | Number with resolved tear at follow up | 2 Participants |
| Subacromial Steroid Bursal Injection | Diagnostic Ultrasound | Incomplete data (lost to follow up) | 0 Participants |
| Subacromial Steroid Bursal Injection | Diagnostic Ultrasound | Number with improved (smaller) tear at follow up | 0 Participants |
| Subacromial Steroid Bursal Injection | Diagnostic Ultrasound | Number with resolved tear at follow up | 2 Participants |
Secondary
Shoulder Pain and Disability Index
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study.
Time frame: Week 6 post procedure SPADI Scores for the treatment and control groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PRP Injection Into PTRCT | Shoulder Pain and Disability Index | 8.00 scores on a scale |
| Subacromial Steroid Bursal Injection | Shoulder Pain and Disability Index | 18.46 scores on a scale |
Secondary
Shoulder Pain and Disability Index
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study.
Time frame: Week 3 post procedure SPADI Scores for the control and treatment groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PRP Injection Into PTRCT | Shoulder Pain and Disability Index | 16.00 scores on a scale |
| Subacromial Steroid Bursal Injection | Shoulder Pain and Disability Index | 18.08 scores on a scale |
Secondary
Shoulder Pain and Disability Index
Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study.
Time frame: 6 months post procedure SPADI scores for the treatment and control groups.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PRP Injection Into PTRCT | Shoulder Pain and Disability Index | 3.08 scores on a scale |
| Subacromial Steroid Bursal Injection | Shoulder Pain and Disability Index | 7.31 scores on a scale |