## Protocol Section
### Identification Module
**NCT ID:** NCT03942679

**Brief Title:** Platelet Rich Plasma and Supraspinatus Tear

**Official Title:** Efficacy of Platelet Rich Plasma Injection in Comparison to Physical Therapy for Treatment of Chronic Partial Supraspinatus Tears

#### Organization Study ID Info
**ID:** MS/17.08.79
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2020-04-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-04-16

**Type:** ACTUAL

**Last Update Submit Date:** 2020-04-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2019-06-01

**Type:** ACTUAL

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2019-05-08
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-07
**Study First Submit QC Date:** 2019-05-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Rheumatology and Rehabilitation Department, Mansoura University Hospital. Forty patients with chronic partial supraspinatus tears will be included in the study. The diagnosis of the supraspinatus tear will be made by ultrasound examination

**Detailed Description:** At inclusion in the study, demographic data (age, gender, duration of complaints, and body mass index) will be recorded.

Randomization

Patients will be randomized into two matched groups:

A) PRP-Injection Group - Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.

B) Physical Therapy Group - Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.

Patients in t

### Conditions Module

**Conditions:**

- Supraspinatus Tear

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 201

**Intervention Names:**

- Other: PRP

**Label:** PRPinjection group

**Type:** OTHER

#### Arm Group 2

**Description:** Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks

**Intervention Names:**

- Other: physiotherapy

**Label:** physiotherapy group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PRPinjection group

**Description:** Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.

**Name:** PRP

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- physiotherapy group

**Description:** Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.

**Name:** physiotherapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain

**Measure:** change of pain from base line

**Time Frame:** immediately before injection,6 weeks after injection,12 weeks after injection

**Description:** III. Examination of passive and active range of motion using goniometer based on the description of norkin and white as following

* Abduction ;170
* Adduction :50
* Flexion :165
* Extension:60
* Internal rotation at 90 abduction :70
* External rotation at 90 abduction :100

**Measure:** change of range of motion from base line

**Time Frame:** immediately before injection,6 weeks after injection,12 weeks after injection

#### Secondary Outcomes

**Description:** •Disability and health related quality of life will be measured using DASH shoulder rating scale.

**Measure:** change of shoulder index score from base line

**Time Frame:** immediately before injection,6 weeks after injection,12 weeks after injection

**Description:** •US documented pathology will be assessed at diagnosis and at 12 weeks.

**Measure:** change of ultrasound pathology from base line

**Time Frame:** immediately before injection,,12 weeks after injection

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

chronic partial supraspinatus tears will be included in the study

Exclusion Criteria:

age \> 80 years, pregnancy, full thickness supraspinatus tears, other rotator cuff lesions with/without supraspinatus tears, systemic disorders such as diabetes rheumatoid arthritis, hematological diseases (co-agulopathy),

**Maximum Age:** 60 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mansoura

**Country:** Egypt

**Facility:** Reham Magdy Shaat

**State:** Dakahlia Provence

**Zip:** 050

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
