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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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ClinicalTrials.gov Identifier: NCT03548662
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE June 7, 2018
Last Update Posted Date June 7, 2018
Actual Study Start Date  ICMJE March 4, 2014
Actual Primary Completion Date February 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • 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
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Official Title  ICMJE The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Tear
Intervention  ICMJE
  • Biological: Platelet-Rich Plasma
    Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA
    Other Name: RegenKit® PRP
  • Drug: Hyaluronic Acid
    Hyruan Plus Inj. produced by LG Life Sciences, Ltd.
    Other Name: Hyruan Plus Inj.
  • 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
Study Arms  ICMJE
  • Experimental: Platelet-Rich Plasma Protein (PRP) Group
    Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise
    Interventions:
    • Biological: Platelet-Rich Plasma
    • Other: Exercise
  • Active Comparator: Hyaluronic Acid Group
    Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise
    Interventions:
    • Drug: Hyaluronic Acid
    • Other: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 6, 2018
Actual Primary Completion Date February 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548662
Other Study ID Numbers  ICMJE 2014-02-005B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taipei Veterans General Hospital, Taiwan
Study Sponsor  ICMJE Taipei Veterans General Hospital, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jia chi Wang, MD Taipei Veteran General hospital
PRS Account Taipei Veterans General Hospital, Taiwan
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP