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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03548662
• Other study ID #: 2014-02-005B
• Status: Completed
• Phase: Phase 1
• Start date: March 4, 2014
• Est. completion date: February 6, 2018

Study information

• Verified date: June 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 6, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

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

Drug:
• Hyaluronic Acid
Hyruan Plus Inj. produced by LG Life Sciences, Ltd.

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

Locations

Country	Name	City	State
Taiwan	Taipei veteran general hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Change is measured from baseline to 1.5 and 3 months
Secondary	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.	Change is measured from baseline to 1.5 and 3 months
Secondary	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).	Change is measured from baseline to 1.5 and 3 months
Secondary	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.	Change is measured from baseline to 1.5 and 3 months