NCT03548662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

3.9 years

First QC Date

October 10, 2017

Last Update Submit

June 6, 2018

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff TearPlatelet Rich PlasmaUltrasoundExerciseHyaluronic Acid

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change is measured from baseline to 1.5 and 3 months

Secondary Outcomes (4)

  • Numeric Pain Rating Scale

    Change is measured from baseline to 1.5 and 3 months

  • Shoulder range of motion

    Change is measured from baseline to 1.5 and 3 months

  • Shoulder Pain and Disability Index (SPADI)

    Change is measured from baseline to 1.5 and 3 months

  • Size of rotator cuff tear

    Change is measured from baseline to 1.5 and 3 months

Study Arms (2)

Platelet-Rich Plasma Protein (PRP) Group

EXPERIMENTAL

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

Biological: Platelet-Rich PlasmaOther: Exercise

Hyaluronic Acid Group

ACTIVE COMPARATOR

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

Drug: Hyaluronic AcidOther: Exercise

Interventions

Platelet-Rich PlasmaBIOLOGICAL

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

Also known as: RegenKit® PRP
Platelet-Rich Plasma Protein (PRP) Group
Hyaluronic AcidDRUG

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

Also known as: Hyruan Plus Inj.
Hyaluronic Acid Group
ExerciseOTHER

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

Hyaluronic Acid GroupPlatelet-Rich Plasma Protein (PRP) Group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei veteran general hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesMotor Activity

Interventions

Hyaluronic AcidExercise

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesBehavior

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jia chi Wang, MD

    Taipei Veteran General hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2017

First Posted

June 7, 2018

Study Start

March 4, 2014

Primary Completion

February 6, 2018

Study Completion

February 6, 2018

Last Updated

June 7, 2018

Record last verified: 2018-06

Locations

TW(1)