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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

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Biological: Platelet-Rich Plasma Drug: Hyaluronic Acid Other: Exercise Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Actual Study Start Date : March 4, 2014
Actual Primary Completion Date : February 6, 2018
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine


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 Name: 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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. 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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548662


Locations
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Taiwan
Taipei veteran general hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Jia chi Wang, MD Taipei Veteran General hospital

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03548662     History of Changes
Other Study ID Numbers: 2014-02-005B
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

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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

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Rotator Cuff Tear
Platelet Rich Plasma
Ultrasound
Exercise
Hyaluronic Acid

Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents