The Effect of Amniotic Membrane Injection as An Addition to Physical Therapy in Patients With Rotator Cuff Tear
Rotator Cuff Tear, Rotator Cuff Tendinopathy, Ultrasonography
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator cuff tear, rotator cuff tendinopathy, amniotic membrane, ultrasonography
Eligibility Criteria
Inclusion Criteria:
- . symptomatic rotator cuff tendinopathy, including partial-thickness tear or small (<1cm) full-thickness tear, proven by ultrasound
- . duration of symptom longer than 1 month
- . age ≥20 years old
Exclusion Criteria:
- .fracture, dislocation, or arthritis of the shoulder
- . previous shoulder joint surgery
- . rotator cuff full-thickness tear with size ≥ 1cm
- . calcification of rotator cuff tendons
- . severe medical comorbidities, e.g., malignant neoplasms, blood dyscrasia, and serious infection, etc.
- . pregnancy
- . cognitive impairment (Mini-Mental Status Examination < 24).
Sites / Locations
- Shin Kong Wu Ho-Su Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Amniotic membrane preparation and injection (AM group)
Physiotherapy (PT group )
The dehydrated AM product used in this study is derived from donated human placental tissue following healthy, live, caesarian section, full-term births which are then cleaned of blood under aseptic conditions. The product comes as a 20mg dry powder in a small vial stored at room temperature and mixed with 2 mL 0.9% sterile normal saline. Then the suspended AM will be injected to the injured tendon and the surrounding area with ultrasound-guidance via a 7cm, 23-gauge needle.
Physiotherapy includes hot pack, electric therapy and therapeutic exercise, which will be supervised by a senior physical therapist. The therapeutic exercise consists of active and passive stretching, and strengthening exercise of the rotator cuff, the shoulder girdle, and the pectoral muscles, and scapular stabilization exercise, 3 times a week, and will be continued for 12 weeks.