Effectiveness of Lyophilized Growth Factors for Subacromial Impingement

Effectiveness of Lyophilized Growth Factors for Subacromial Impingement: Randomized Double Blind Placebo Controlled Study

The aim of this study is to evaluate the efficacy of ultrasound-guided injection of platelet-derived lyophilized growth factors in treatment of subacromial impingement.

Study Overview

• Status: Unknown
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Biological: Growth factors; Other: Saline

Detailed Description

A new patented product named lyophilized Growth Factors has been developed. It is a novel advanced and refined form of conventional platelet-rich plasma. Effectiveness of intra-articular lyophilized Growth Factors injection has been studied in thirty patients with symptomatic primary knee osteoarthritis and has shown encouraging results regarding improvement of pain, stiffness and function in addition to decreasing knee effusion.

The lack of good quality evidence to support the efficacy of injecting platelet-derived lyophilized growth factors in treatment of subacromial impingement highlights the need for thorough evaluation of the outcome of this novel therapeutic option in patients with subacromial impingement.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jailan Noureldin; Phone Number: 00201008387898; Email: jailan_ashraf@outlook.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University Hospitals
    • Contact: Jailan Ashraf; Phone Number: 00201008387898; Email: jailan_ashraf@outlook.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Clinically:

  1. Anterolateral shoulder and/or lateral upper arm pain.
  2. Painful arc of motion between 70° and 120°.
  3. Positive impingement sign (Neer's test or Hawkins-Kennedy test).
• Ultrasonographically:

The elicitation of a transient arc of pain during shoulder abduction which coincides with passage of the supraspinatus insertion beneath the coraco-acromial arch.

Exclusion Criteria:

• History of shoulder surgery, fracture, dislocation or subluxation.
• Patients with full-thickness rotator cuff tear, weakness on arm elevation, or positive "drop arm sign".
• Patients who have been diagnosed with a frozen shoulder or degenerative arthropathy of the glenohumeral joint.
• Patients with disorders of the cervical spine or upper extremity that have a significant impact on the shoulder
• Patients with diabetes mellitus, rheumatoid arthritis, hypothyroidism or other painful or function limiting disorders of the shoulder.
• Significant cardiovascular, renal or hepatic disease.
• Active infection in the area to be treated.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Growth factors; Patients in this group will receive one lyophilized Growth Factors injection supplied as a powder in a tightly sealed container.	Biological: Growth factors; A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma
Placebo Comparator: Saline; Patients in this group will receive an injection with equal volume of saline; i.e 2ml of 0.9% sodium chloride.	Other: Saline; 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS (Visual Analogue Scale)	Pain assessment scale. The minimum value is zero and the maximum value is 10. A higher score indicates a worse outcome.	8 weeks
SPADI (Shoulder Pain and Disability Index)	An index measuring the impact of shoulder pathology in terms of pain and disability. Total pain score: / 50 x 100 = % Total disability score: / 80 x 100 = % Total Spadi score: / 130 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 120) The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst). A higher score indicates a worse outcome.	8 weeks

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Jailan Noureldin, Alexandria University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: 0106178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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