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

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet-Rich Plasma
Hyaluronic Acid
Exercise
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear, Platelet Rich Plasma, Ultrasound, Exercise, Hyaluronic Acid

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei veteran general hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet-Rich Plasma Protein (PRP) Group

Hyaluronic Acid Group

Arm Description

Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise

Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise

Outcomes

Primary Outcome Measures

Constant-Murley shoulder score
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.

Secondary Outcome Measures

Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NRS) is a 11-point numeric scale ranges from '0' representing no pain to '10' representing worst pain imaginable
Shoulder range of motion
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.
Shoulder Pain and Disability Index (SPADI)
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).
Size of rotator cuff tear
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.

Full Information

First Posted
October 10, 2017
Last Updated
June 6, 2018
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03548662
Brief Title
The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Official Title
The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 4, 2014 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Rotator Cuff Tear, Platelet Rich Plasma, Ultrasound, Exercise, Hyaluronic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-Rich Plasma Protein (PRP) Group
Arm Type
Experimental
Arm Description
Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
Arm Title
Hyaluronic Acid Group
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
Intervention Type
Biological
Intervention Name(s)
Platelet-Rich Plasma
Other Intervention Name(s)
RegenKit® PRP
Intervention Description
Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
Hyruan Plus Inj.
Intervention Description
Hyruan Plus Inj. produced by LG Life Sciences, Ltd.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Constant-Murley shoulder score
Description
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.
Time Frame
Change is measured from baseline to 1.5 and 3 months
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The Numeric Pain Rating Scale (NRS) is a 11-point numeric scale ranges from '0' representing no pain to '10' representing worst pain imaginable
Time Frame
Change is measured from baseline to 1.5 and 3 months
Title
Shoulder range of motion
Description
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.
Time Frame
Change is measured from baseline to 1.5 and 3 months
Title
Shoulder Pain and Disability Index (SPADI)
Description
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).
Time Frame
Change is measured from baseline to 1.5 and 3 months
Title
Size of rotator cuff tear
Description
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.
Time Frame
Change is measured from baseline to 1.5 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia chi Wang, MD
Organizational Affiliation
Taipei Veteran General hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei veteran general hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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

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