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

NCT05320419 | Completed DMC

• 1 other identifier: 20210711R
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear; Rotator Cuff Tendinopathy; Ultrasonography

Keywords

Rotator cuff tear; rotator cuff tendinopathy; amniotic membrane; ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.

Secondary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.

Other Outcomes (4)

• American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

  change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.

• Range of motion.

  change between baseline and at 12 weeks, and 24 weeks after the beginning of the treatment.

• Ultrasound image of the rotator cuff of the affected shoulder

  change between baseline and at 4 weeks, 12 weeks, and 24 weeks after the beginning of the treatment.

Study Arms (2)

Amniotic membrane preparation and injection (AM group)

ACTIVE COMPARATOR

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.

Other: Physiotherapy (PT group)

Physiotherapy (PT group )

ACTIVE COMPARATOR

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.

Other: Amniotic membrane preparation and injection (AM group)

Interventions

Amniotic membrane preparation and injection (AM group) OTHER

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 (PT group )

Physiotherapy (PT group) OTHER

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.

Amniotic membrane preparation and injection (AM group)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Injections; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Rehabilitation

Study Officials

• Lin-Fen Hsieh

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 11, 2022
• Study Start: March 29, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

TW (1)