Clinical trial NCT02246530: Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
Official title: Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Partial Tear of Rotator Cuff
Tendinopathy of Rotator Cuff
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Ultrasound
timeFrame: 6 months post procedure
Secondary outcomes:
measure: Shoulder Pain and Disability Index
timeFrame: Week 3 post procedure SPADI Scores for the control and treatment groups.
measure: Shoulder Pain and Disability Index
timeFrame: Week 6 post procedure SPADI Scores for the treatment and control groups.
measure: Shoulder Pain and Disability Index
timeFrame: 6 months post procedure SPADI scores for the treatment and control groups.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Highlands
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Breanna Willeford, DO
role: PRINCIPAL_INVESTIGATOR
References: