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The Effect of Amniotic Membrane Injection as An Addition to Physical Therapy in Patients With Rotator Cuff Tear

S

Shin Kong Wu Ho-Su Memorial Hospital

Status

Completed

Conditions

Rotator Cuff Tear
Ultrasonography
Rotator Cuff Tendinopathy

Treatments

Other: Physiotherapy (PT group)
Other: Amniotic membrane preparation and injection (AM group)

Study type

Interventional

Funder types

Other

Identifiers

NCT05320419
20210711R

Details and patient eligibility

About

Rotator cuff tear (RCT) is a commonly seen pathology in shoulder disease, which causes significant disability in daily living and work. Based on a cohort study of a large population, the prevalence of rotator cuff full-thickness tear was 20.7%. More broadly, the prevalence of rotator cuff abnormalities increased with age and up to 62% in population more than 80 years old. The pathophysiology of RCT could be attributed to extrinsic factors such as impingement by surrounding tissue and intrinsic factor such as tendon degeneration. According to previous study using histochemical and immunocytochemical techniques, fibrocartilaginous metaplasia, decreasing vascularity and fibroblast numbers were found in rotator cuff tear. Besides, the inflammatory response diminished as the tear size increased.

The treatment of RCT includes surgery and non-operative treatment. The prognosis depends on the symptoms, tear size, chronicity and other structures involvement. Previous meta-analysis study reported that the effectiveness between surgery and conservative treatment is similar in treating RCT. Therefore, relative rest, oral medication, physical therapy and injection therapy were commonly used in first-line treatments. When treating shoulder pain with injection therapy, steroid was often used at first for short-term pain relief and anti-inflammation. However, the potential cytotoxic effect was found and could be harmful in tendon repair. To accelerative the healing process of soft tissue injury, regenerative injection become more popular and expectable over past few years. A meta-analysis study reported the positive long-term effect of prolotherapy and platelet-rich plasma (PRP). More recently, bone marrow concentrate (BMC) and amniotic membrane (AM) have been used in soft tissue repair and many clinical studies are processing.

Full description

Rotator cuff tear (RCT) is a commonly seen pathology in shoulder disease, which causes significant disability in daily living and work. Based on a cohort study of a large population, the prevalence of rotator cuff full-thickness tear was 20.7%. More broadly, the prevalence of rotator cuff abnormalities increased with age and up to 62% in population more than 80 years old. The pathophysiology of RCT could be attributed to extrinsic factors such as impingement by surrounding tissue and intrinsic factor such as tendon degeneration. According to previous study using histochemical and immunocytochemical techniques, fibrocartilaginous metaplasia, decreasing vascularity and fibroblast numbers were found in rotator cuff tear. Besides, the inflammatory response diminished as the tear size increased.

The treatment of RCT includes surgery and non-operative treatment. The prognosis depends on the symptoms, tear size, chronicity and other structures involvement. Previous meta-analysis study reported that the effectiveness between surgery and conservative treatment is similar in treating RCT. Therefore, relative rest, oral medication, physical therapy and injection therapy were commonly used in first-line treatments. When treating shoulder pain with injection therapy, steroid was often used at first for short-term pain relief and anti-inflammation. However, the potential cytotoxic effect was found and could be harmful in tendon repair. To accelerative the healing process of soft tissue injury, regenerative injection become more popular and expectable over past few years. A meta-analysis study reported the positive long-term effect of prolotherapy and platelet-rich plasma (PRP). More recently, bone marrow concentrate (BMC) and amniotic membrane (AM) have been used in soft tissue repair and many clinical studies are processing.

In recent decades, PRP was widely used in soft tissue regeneration. Though many studies had discussed the effect of PRP injections on pain and shoulder function in RCT, the effectiveness remains controversial. Some newer scaffolds including bovine collagen and amnio-derived membranes were also applied to the RCT in recent years. The AM was separated from a donor's placenta, and is a non-immunogenic structure. In previous animal study, amniotic epithelial cells could produce transforming growth factor-β (TGF-β), basic fibroblast growth factor (bFGF), epidermal growth factor (EGF), transforming growth factor-α (TGF-α), keratinocyte growth factor and hepatocyte growth factor. AM was found having anti-inflammatory, antimicrobial, antiviral effect, regulatory effect on angiogenesis and anti-scarring effcts. AM was revealed a pluripotent tissue which makes it potential in regenerative medicine. In some case series research, positive results was reported in pain and shoulder function in rotator cuff tears.

To the best of our knowledge, there has been limited evidence of regenerative injection by AM in treating patients with rotator cuff tear. The aim of this study is to evaluate the effect of single injection of AM in addition to physical therapy on pain and shoulder function.

Enrollment

7 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. . symptomatic rotator cuff tendinopathy, including partial-thickness tear or small (<1cm) full-thickness tear, proven by ultrasound
  2. . duration of symptom longer than 1 month
  3. . age ≥20 years old

Exclusion criteria

  1. .fracture, dislocation, or arthritis of the shoulder
  2. . previous shoulder joint surgery
  3. . rotator cuff full-thickness tear with size ≥ 1cm
  4. . calcification of rotator cuff tendons
  5. . severe medical comorbidities, e.g., malignant neoplasms, blood dyscrasia, and serious infection, etc.
  6. . pregnancy
  7. . cognitive impairment (Mini-Mental Status Examination < 24).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups

Amniotic membrane preparation and injection (AM group)
Active Comparator group
Description:
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.
Treatment:
Other: Physiotherapy (PT group)
Physiotherapy (PT group )
Active Comparator group
Description:
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.
Treatment:
Other: Amniotic membrane preparation and injection (AM group)

Trial contacts and locations

1

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Central trial contact

Lin-Fen Hsieh

Data sourced from clinicaltrials.gov

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