Clinical trial NCT03548662: The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Official title: The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rotator Cuff Tear
Keywords: Rotator Cuff Tear
Platelet Rich Plasma
Ultrasound
Exercise
Hyaluronic Acid
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-06-07
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Constant-Murley shoulder score
timeFrame: Change is measured from baseline to 1.5 and 3 months
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Change is measured from baseline to 1.5 and 3 months
measure: Shoulder range of motion
timeFrame: Change is measured from baseline to 1.5 and 3 months
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Change is measured from baseline to 1.5 and 3 months
measure: Size of rotator cuff tear
timeFrame: Change is measured from baseline to 1.5 and 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei veteran general hospital
Study officials:
affiliation: Taipei Veteran General hospital
name: Jia chi Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: