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Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

Primary Purpose

Chronic Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
platelet rich plasm
Hyaluronic acid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Shoulder Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient age >18 years.
  • Patients with chronic shoulder pain more than 6 months not responding to medical treatment or physical therapy.
  • Frozen shoulder.
  • Rotator cuff disorders (partial tear).

Exclusion Criteria:

  • Shoulder joint instability or traumatic shoulder pain.
  • Patients with local infection at the shoulder, systemic infection, or inflammatory disease (e.g., rheumatoid arthritis and hepatitis)
  • Patients with a history of diabetes mellitus and malignancy (either hematological or non-hematological).
  • Pregnancy.
  • Patients on anticoagulant therapy.
  • Injection of shoulder with corticosteroids in the preceding 6 months.

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

25 patient with chronic shoulder pain injected with platelet rich plasm

25 patient with chronic shoulder pain injected with Hyaluronic acid

Arm Description

patients with chronic shoulder pain injected with platelet rich plasm ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI)

patients with chronic shoulder pain injected with Hyaluronic acid ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI)

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
0-10 visual analogue scale of pain
Visual Analogue Scale (VAS)
0-10 visual analogue scale of pain
Constant score (CS)
This scoring system combines physical examination tests with subjective evaluations by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (20 points) (work 4, sport 4, sleep2 and positioning the hand in space 10 points). The objective assessment includes: range of motion (40 points) (forward elevation, 10 points; lateral elevation, 10 points; internal rotation, 10 points; external rotation, 10 points) and power (25 points) (scoring based on the number of pounds of pull the patient can resist in abduction to a maximum of 25 points). The total possible score is therefore 100 points.
Constant score (CS)
This scoring system combines physical examination tests with subjective evaluations by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (20 points) (work 4, sport 4, sleep2 and positioning the hand in space 10 points). The objective assessment includes: range of motion (40 points) (forward elevation, 10 points; lateral elevation, 10 points; internal rotation, 10 points; external rotation, 10 points) and power (25 points) (scoring based on the number of pounds of pull the patient can resist in abduction to a maximum of 25 points). The total possible score is therefore 100 points.
Shoulder Pain and Disability Index (SPADI) questionnaire
is a self-introduction administered index designed to measure the effects of different pathologic conditions on the functional status of the shoulder. All items are rated by using a visual analogue scale from "no pain" or "no difficulty" to "worst imaginable pain" or "so difficult it required help". A numerical value was obtained by dividing the scale into 11 segments from 0 to 10 for each item
Shoulder Pain and Disability Index (SPADI) questionnaire
is a self-introduction administered index designed to measure the effects of different pathologic conditions on the functional status of the shoulder. All items are rated by using a visual analogue scale from "no pain" or "no difficulty" to "worst imaginable pain" or "so difficult it required help". A numerical value was obtained by dividing the scale into 11 segments from 0 to 10 for each item

Secondary Outcome Measures

Full Information

First Posted
September 18, 2021
Last Updated
October 6, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05072899
Brief Title
Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder
Official Title
Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder: Randomized Comparative Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
Aim of This study is to compare between the effect of ultrasound-guided local injection of Platelet Rich Plasma (PRP)versus Hyaluronic (HA) for the treatment of chronic shoulder pain.
Detailed Description
This study was prospective randomized comparative trial on patients with chronic shoulder pain presented at outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation Department at Assiut University Hospitals from June 2019 to December 2020. Our study started by 70 patient with chronic shoulder pain 20 of them were missed in follow up period, the range of age from 36 - 56 years, history, clinical examination, Laboratory investigation, and imaging (X-ray or MRI) done for all patient to complete the diagnosis, patient divided randomly into two groups, Group (A) included 25 patients were treated by PRP injection and group (B) included 25 patients were treated by HA injection, both injections were performed under ultrasound (US) guidance. Randomization by sealed envelopes technique, the follow up was at the baseline, 4 weeks and 6 months post injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25 patient with chronic shoulder pain injected with platelet rich plasm
Arm Type
Experimental
Arm Description
patients with chronic shoulder pain injected with platelet rich plasm ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI)
Arm Title
25 patient with chronic shoulder pain injected with Hyaluronic acid
Arm Type
Experimental
Arm Description
patients with chronic shoulder pain injected with Hyaluronic acid ultrasound guided, assessment done on initial visit and follow up after 4weeks and 6month using (VAS, CS, SPADI)
Intervention Type
Procedure
Intervention Name(s)
platelet rich plasm
Intervention Description
local injection of shoulder joint by platelet rich plasm
Intervention Type
Procedure
Intervention Name(s)
Hyaluronic acid
Intervention Description
local injection of shoulder joint by Hyaluronic acid
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
0-10 visual analogue scale of pain
Time Frame
4weeks post injection follow up.
Title
Visual Analogue Scale (VAS)
Description
0-10 visual analogue scale of pain
Time Frame
6 months post injection follow up
Title
Constant score (CS)
Description
This scoring system combines physical examination tests with subjective evaluations by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (20 points) (work 4, sport 4, sleep2 and positioning the hand in space 10 points). The objective assessment includes: range of motion (40 points) (forward elevation, 10 points; lateral elevation, 10 points; internal rotation, 10 points; external rotation, 10 points) and power (25 points) (scoring based on the number of pounds of pull the patient can resist in abduction to a maximum of 25 points). The total possible score is therefore 100 points.
Time Frame
4weeks post injection follow up.
Title
Constant score (CS)
Description
This scoring system combines physical examination tests with subjective evaluations by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (20 points) (work 4, sport 4, sleep2 and positioning the hand in space 10 points). The objective assessment includes: range of motion (40 points) (forward elevation, 10 points; lateral elevation, 10 points; internal rotation, 10 points; external rotation, 10 points) and power (25 points) (scoring based on the number of pounds of pull the patient can resist in abduction to a maximum of 25 points). The total possible score is therefore 100 points.
Time Frame
6 months post injection follow up
Title
Shoulder Pain and Disability Index (SPADI) questionnaire
Description
is a self-introduction administered index designed to measure the effects of different pathologic conditions on the functional status of the shoulder. All items are rated by using a visual analogue scale from "no pain" or "no difficulty" to "worst imaginable pain" or "so difficult it required help". A numerical value was obtained by dividing the scale into 11 segments from 0 to 10 for each item
Time Frame
4weeks post injection follow up.
Title
Shoulder Pain and Disability Index (SPADI) questionnaire
Description
is a self-introduction administered index designed to measure the effects of different pathologic conditions on the functional status of the shoulder. All items are rated by using a visual analogue scale from "no pain" or "no difficulty" to "worst imaginable pain" or "so difficult it required help". A numerical value was obtained by dividing the scale into 11 segments from 0 to 10 for each item
Time Frame
6 months post injection follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient age >18 years. Patients with chronic shoulder pain more than 6 months not responding to medical treatment or physical therapy. Frozen shoulder. Rotator cuff disorders (partial tear). Exclusion Criteria: Shoulder joint instability or traumatic shoulder pain. Patients with local infection at the shoulder, systemic infection, or inflammatory disease (e.g., rheumatoid arthritis and hepatitis) Patients with a history of diabetes mellitus and malignancy (either hematological or non-hematological). Pregnancy. Patients on anticoagulant therapy. Injection of shoulder with corticosteroids in the preceding 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman H El-Hakeim, A.Professor
Organizational Affiliation
Assiut University-faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

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Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

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