Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02246530
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 80
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Partial Tear of Rotator Cuff; Tendinopathy of Rotator Cuff	Procedure: PRP injection into PTRCT; Drug: Subacromial steroid bursal injection	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
• Actual Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PRP injection into PTRCT Treatment - PRP injection	Procedure: 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.; Other Names: Biologics
Active Comparator: Subacromial steroid bursal injection Current standard of care for treatment of resistant partial thickness rotator cuff tears	Drug: 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; Other Names: Procedure

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Shoulder Pain and Disability Index [Week 6 post procedure SPADI Scores for the treatment and control 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.

3. Shoulder Pain and Disability Index [6 months post procedure SPADI scores for the treatment and control 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Highlands	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Breanna Willeford, DO, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol - Jul 4, 2014

More Information

Publications

None provided.

• Responsible Party: Breanna Willeford, Resident Physician, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02246530
• Other Study ID Numbers: F131231006
• First Posted: Sep 22, 2014
• Last Update Posted: May 16, 2022
• Last Verified: May 1, 2022

• Additional relevant MeSH terms: Tendinopathy; Rotator Cuff Injuries

Study Results

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 Detail	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.

Arm/Group Title	PRP Injection Into PTRCT	Subacromial Steroid Bursal Injection
Arm/Group Description	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.	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
Period Title: Overall Study
STARTED	9	2
COMPLETED	5	2
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	PRP Injection Into PTRCT	Subacromial Steroid Bursal Injection	Total
Arm/Group Description	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.	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	Total of all reporting groups
Overall Participants	5	2	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	2 100%	7 100%
>=65 years	0 0%	0 0%	0 0%
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	48.13	57.5	50
Sex: Female, Male (Count of Participants)
Female	3 60%	1 50%	4 57.1%
Male	2 40%	1 50%	3 42.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	5 100%	2 100%	11 157.1%
SPADI (Shoulder Pain and Disability Index) Score (SPADI Score) [Mean (Full Range) ]
Mean (Full Range) [SPADI Score]	43.69	23.08	37.80

Outcome Measures

1. Primary Outcome

Title	Diagnostic Ultrasound
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRP Injection Into PTRCT	Subacromial Steroid Bursal Injection
Arm/Group Description	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.	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
Measure Participants	5	2
Incomplete data (lost to follow up)	1 20%	0 0%
Number with improved (smaller) tear at follow up	2 40%	0 0%
Number with resolved tear at follow up	2 40%	2 100%

2. Secondary Outcome

Title	Shoulder Pain and Disability Index
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRP Injection Into PTRCT	Subacromial Steroid Bursal Injection
Arm/Group Description	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.	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
Measure Participants	5	2
Mean (Full Range) [scores on a scale]	16.00	18.08

3. Secondary Outcome

Title	Shoulder Pain and Disability Index
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRP Injection Into PTRCT	Subacromial Steroid Bursal Injection
Arm/Group Description	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.	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
Measure Participants	5	2
Mean (Full Range) [scores on a scale]	8.00	18.46

4. Secondary Outcome

Title	Shoulder Pain and Disability Index
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRP Injection Into PTRCT	Subacromial Steroid Bursal Injection
Arm/Group Description	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.	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
Measure Participants	5	2
Mean (Full Range) [scores on a scale]	3.08	7.31

Adverse Events

Time Frame	Patients were observed and monitored for adverse events up to 6 months post-procedure
Arm/Group Title	PRP Injection Into PTRCT		Subacromial Steroid Bursal Injection
Arm/Group Description	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.		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
All Cause Mortality
	PRP Injection Into PTRCT		Subacromial Steroid Bursal Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/2 (0%)
Serious Adverse Events
	PRP Injection Into PTRCT		Subacromial Steroid Bursal Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	PRP Injection Into PTRCT		Subacromial Steroid Bursal Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.