Effectiveness of Lyophilized Growth Factors for Subacromial Impingement

Study Overview
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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.

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.

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

Conditions
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Shoulder Impingement Syndrome

Intervention / Treatment
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* Biological: Growth factors
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically: Anterolateral shoulder and/or lateral upper arm pain. Painful arc of motion between 70° and 120°. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |