Effectiveness of Lyophilized Growth Factors for Subacromial Impingement

Alexandria University

Status: Unknown

Conditions: Shoulder Impingement Syndrome

Treatments: Biological: Growth factors; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04330027

0106178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Growth factors

Experimental group

Description:

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

Treatment:

Biological: Growth factors

Saline

Placebo Comparator group

Description:

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

Treatment:

Other: Saline