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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05072899
Other study ID # Faculty of medicine Assiut uni
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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