Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder

NCT05072899 | Completed

• 1 other identifier: Faculty of medicine Assiut uni
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Shoulder Pain

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

25 patient with chronic shoulder pain injected with platelet rich plasm

EXPERIMENTAL

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

25 patient with chronic shoulder pain injected with Hyaluronic acid

EXPERIMENTAL

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

Interventions

platelet rich plasm PROCEDURE

local injection of shoulder joint by platelet rich plasm

25 patient with chronic shoulder pain injected with platelet rich plasm

Hyaluronic acid PROCEDURE

local injection of shoulder joint by Hyaluronic acid

25 patient with chronic shoulder pain injected with Hyaluronic acid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Eman H El-Hakeim, A.Professor

  Assiut University-faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: October 11, 2021
• Study Start: June 15, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 11, 2021

Record last verified: 2021-10

Locations

EG (1)