Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

Chronic Shoulder Pain Clinical Trial

Official title:

Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder: Randomized Comparative Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072899
• Other study ID #: Faculty of medicine Assiut uni
• Status: Completed
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain

Intervention

Procedure:
• platelet rich plasm
local injection of shoulder joint by platelet rich plasm
• Hyaluronic acid
local injection of shoulder joint by Hyaluronic acid

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	0-10 visual analogue scale of pain	4weeks post injection follow up.
Primary	Visual Analogue Scale (VAS)	0-10 visual analogue scale of pain	6 months post injection follow up
Primary	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.	4weeks post injection follow up.
Primary	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.	6 months post injection follow up
Primary	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	4weeks post injection follow up.
Primary	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	6 months post injection follow up