Effectiveness of Lyophilized Growth Factors for Subacromial Impingement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Shoulder Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Growth factors

Patients in this group will receive one lyophilized Growth Factors injection supplied as a powder in a tightly sealed container.

Group Type EXPERIMENTAL

Growth factors

Intervention Type BIOLOGICAL

A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma

Saline

Patients in this group will receive an injection with equal volume of saline; i.e 2ml of 0.9% sodium chloride.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

0.9% Sodium Chloride

Interventions

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Growth factors

A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma

Intervention Type BIOLOGICAL

Saline

0.9% Sodium Chloride

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No