Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

NCT ID: NCT05072899

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2020-12-30

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.

Conditions

Chronic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

platelet rich plasm

Intervention Type: PROCEDURE

local injection of shoulder joint by platelet rich plasm

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)

Group Type: EXPERIMENTAL

Hyaluronic acid

Intervention Type: PROCEDURE

local injection of shoulder joint by Hyaluronic acid

Interventions

platelet rich plasm

local injection of shoulder joint by platelet rich plasm

Intervention Type: PROCEDURE

Hyaluronic acid

local injection of shoulder joint by Hyaluronic acid

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman Mohamed H. ElHakeim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman H El-Hakeim, A.Professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University-faculty of medicine

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Faculty of medicine Assiut uni

Identifier Type: -

Identifier Source: org_study_id