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Completed

NCT Number: NCT03548662

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

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

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Key information

Conditions

Rotator Cuff Tear Behavior Motor Activity Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taipei veteran general hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-Rich Plasma

Biological

Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA

Other names: RegenKit® PRP

Hyaluronic acid

Drug

Hyruan Plus Inj. produced by LG Life Sciences, Ltd.

Other names: Hyruan Plus Inj.

Exercise

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2018
Registry last updated
Jun 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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