Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Shoulder Pain
• Intervention / Treatment: Procedure: platelet rich plasm; Procedure: Hyaluronic acid

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 25 patient with chronic shoulder pain injected with platelet rich plasm; 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)	Procedure: platelet rich plasm; local injection of shoulder joint by platelet rich plasm
Experimental: 25 patient with chronic shoulder pain injected with Hyaluronic acid; 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)	Procedure: Hyaluronic acid; local injection of shoulder joint by Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	0-10 visual analogue scale of pain	4weeks post injection follow up.
Visual Analogue Scale (VAS)	0-10 visual analogue scale of pain	6 months post injection follow up
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.
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
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.
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Eman H El-Hakeim, A.Professor, Assiut university-Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: September 18, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: Faculty of medicine Assiut uni

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No