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

Primary Purpose

Rotator Cuff Tear, Rotator Cuff Tendinopathy, Ultrasonography

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Amniotic membrane preparation and injection (AM group)
Physiotherapy (PT group)
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Amniotic membrane preparation and injection (AM group)

Physiotherapy (PT group )

Arm 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.

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.

Outcomes

Primary Outcome Measures

Pain Visual Analogue Scale (VAS)
The pain VAS during Neer test will be obtained using a horizontal line of 100 mm, with 0 on the left indicating no pain and 100 on the right indicating very severe pain. A pain VAS has been shown to be reliable and sensitive for quantifying pain, with test-retest reliability of >0.90.24 In previous studies of patients treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.

Secondary Outcome Measures

Shoulder Pain and Disability Index (SPADI)
The SPADI is a self-administered questionnaire to assess the pain and disability associated with shoulder diseases. It consists of 13 items being divided into 2 subclasses, 5 items for pain and 8 items for disabilities. The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses. Good validity and reliability had been proved in previous studies.

Full Information

First Posted
February 8, 2022
Last Updated
April 17, 2023
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05320419
Brief Title
The Effect of Amniotic Membrane Injection as An Addition to Physical Therapy in Patients With Rotator Cuff Tear
Official Title
The Effect of Amniotic Membrane Injection as An Addition to Physical Therapy in Patients With Rotator Cuff Tear
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear, Rotator Cuff Tendinopathy, Ultrasonography
Keywords
Rotator cuff tear, rotator cuff tendinopathy, amniotic membrane, ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amniotic membrane preparation and injection (AM group)
Arm Type
Active Comparator
Arm 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.
Arm Title
Physiotherapy (PT group )
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Amniotic membrane preparation and injection (AM group)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy (PT group)
Intervention 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.
Primary Outcome Measure Information:
Title
Pain Visual Analogue Scale (VAS)
Description
The pain VAS during Neer test will be obtained using a horizontal line of 100 mm, with 0 on the left indicating no pain and 100 on the right indicating very severe pain. A pain VAS has been shown to be reliable and sensitive for quantifying pain, with test-retest reliability of >0.90.24 In previous studies of patients treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.
Time Frame
change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.
Secondary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Description
The SPADI is a self-administered questionnaire to assess the pain and disability associated with shoulder diseases. It consists of 13 items being divided into 2 subclasses, 5 items for pain and 8 items for disabilities. The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses. Good validity and reliability had been proved in previous studies.
Time Frame
change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.
Other Pre-specified Outcome Measures:
Title
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
Description
The ASES is a composite instrument, requiring both a physician assessment and a patient-completed portion; however, it is commonly presented as solely the patient-reported survey. This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a higher score indicating a better shoulder condition. The minimal detectable change was 9.7 points, and the minimal clinically important difference was 6.4 points.
Time Frame
change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.
Title
Range of motion.
Description
The passive ROMs of the affected shoulder will be measured using a goniometer with the guidelines of the American Academy of Orthopedic Surgeons.22 This measurement includes abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction. These ROM measurements of the shoulder using goniometer have been reported to have high inter-trial reliability when they are performed by the same physical therapist.
Time Frame
change between baseline and at 12 weeks, and 24 weeks after the beginning of the treatment.
Title
Ultrasound image of the rotator cuff of the affected shoulder
Description
EPIQ 5 (Phillips, USA) machine with a 18- to 4-MHz linear array transducer will be used for ultrasonographic examinations of the shoulder. The examination will be performed with the subjects in seated position and will be started from the biceps tendon, subscapularis tendon, supraspinatus tendon, infraspinatus tendon, and subacromial-subdeltoid bursa in both the transverse and longitudinal planes. AC joint will also be examined in the longitudinal plane.
Time Frame
change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.
Title
Self-assessment of the treatment effect.
Description
Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=5, effective=4, not effective=3, worse=2, much worse=1).
Time Frame
change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin-Fen Hsieh
Phone
+886-28332211
Ext
2538
Email
M001026@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh, M.D.
Phone
+886-28332211
Ext
2538
Email
M001026@ms.skh.org.tw

12. IPD Sharing Statement

Learn more about this trial

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

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