The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear

June 6, 2018 updated by: Taipei Veterans General Hospital, Taiwan
This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to exam the outcome of rotator cuff tear patients who received platelet rich plasma injection followed by rehabilitative exercise. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with platelet rich plasma (PRP) and rehabilitative exercise. Subjects with partial thickness rotator cuff tears will be designated to receive an injection of PRP or hyaluronic acid, followed by rehabilitative exercise. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for 3 months to determine the outcomes of the treatment.

The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with PRP injections plus rehabilitative exercise compared with hyaluronic acid injection plus rehabilitative exercise for the treatment of partial thickness rotator cuff tears.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Veteran General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 40 and 85 years old, without significant cognition impairment (MMSE>20)
  • Shoulder pain score(NRS)> 5
  • Partial tear of supraspinatus tendon, proved by ultrasonography or MRI
  • Patients who signed informed consent
  • Patients who agreed to stop using analgesics during the experimental period

Exclusion Criteria:

  • Thrombocytopenia (platelets less than 15000 per microliter)
  • Patient who is using anticoagulant or has history of coagulation dysfunction
  • Uncontrolled infection
  • End stage malignant disease
  • Infection or other skin condition over injection site
  • History of shoulder or humeral fracture, dislocation or operation
  • Psychiatric problems that precludes informed consent or inability to read or write
  • Other serious problems that preclude participation of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet-Rich Plasma Protein (PRP) Group
Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
Biological: Platelet-Rich Plasma
Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA
Other Names:
  • RegenKit® PRP
Other: Exercise
passive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise
Active Comparator: Hyaluronic Acid Group
Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
Other: Exercise
passive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise
Drug: Hyaluronic Acid
Hyruan Plus Inj. produced by LG Life Sciences, Ltd.
Other Names:
  • Hyruan Plus Inj.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley shoulder score
Time Frame: Change is measured from baseline to 1.5 and 3 months
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Change is measured from baseline to 1.5 and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: Change is measured from baseline to 1.5 and 3 months
The Numeric Pain Rating Scale (NRS) is a 11-point numeric scale ranges from '0' representing no pain to '10' representing worst pain imaginable
Change is measured from baseline to 1.5 and 3 months
Shoulder range of motion
Time Frame: Change is measured from baseline to 1.5 and 3 months
The shoulder range of motion (ROM) is measured in both active and passive manner and in four direction including flexion, extension, internal rotation and external rotation.
Change is measured from baseline to 1.5 and 3 months
Shoulder Pain and Disability Index (SPADI)
Time Frame: Change is measured from baseline to 1.5 and 3 months
SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. The scores from both domains are averaged to derive a total score with 0 being the best outcome (less disability) and 100 the worst (greater disability).
Change is measured from baseline to 1.5 and 3 months
Size of rotator cuff tear
Time Frame: Change is measured from baseline to 1.5 and 3 months
Rotator cuff tear size will be determined using ultrasound imaging. The image will be conducted in sagittal plan, transverse plan and will measure the maximal size of tear.
Change is measured from baseline to 1.5 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Jia chi Wang, MD, Taipei Veteran General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2014

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

February 6, 2018

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-02-005B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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