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Study terminated prematurely due to inability to complete recruitment of subjects for each of the trial groups (treatment and control).
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP injection into PTRCT | Active Comparator | Treatment - PRP injection |
|
| Subacromial steroid bursal injection | Active Comparator | Current standard of care for treatment of resistant partial thickness rotator cuff tears |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP injection into PTRCT | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Breanna Willeford, DO | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Highlands | Birmingham | Alabama | 35294 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 6 months post procedure |
|
Patients were observed and monitored for adverse events up to 6 months post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Breanna Willeford, DO | University of Alabama at Birmingham | 205-934-4131 | breannawilleford@uabmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2014 | May 12, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| D008722 | Methods |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
| D008919 | Investigative Techniques |
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| Subacromial steroid bursal injection | Drug | Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound |
|
|
| Week 3 post procedure SPADI Scores for the control and treatment groups. |
| 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. | Week 6 post procedure SPADI Scores for the treatment and control groups. |
| 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. | 6 months post procedure SPADI scores for the treatment and control groups. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| SPADI (Shoulder Pain and Disability Index) Score | Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores pre-intervention in each group. 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 divided by 130). Thus the final score is a range of 0% to 100%. | Mean | Full Range | SPADI Score |
|
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Full Range | scores on a scale | Week 3 post procedure SPADI Scores for the control and treatment groups. |
|
|
|
| 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. | Posted | Mean | Full Range | scores on a scale | Week 6 post procedure SPADI Scores for the treatment and control groups. |
|
|
|
| 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. | Posted | Mean | Full Range | scores on a scale | 6 months post procedure SPADI scores for the treatment and control groups. |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
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