Effectiveness of Lyophilized Growth Factors Injection for Subacromial Impingement Syndrome: A Prospective Randomized Double-Blind Placebo Controlled Study

Abstract

Abstract ObjectiveEvaluate efficacy of platelet-derived lyophilized growth factors (L-GF) injection versus placebo in treatment of subacromial impingement (SIS).MethodsSixty patients with SIS (clinically and sonographically) were included in this randomized double blind placebo controlled study. Patients were randomly divided to receive either saline (group 1) or L-GF (group 2) injection, under US-guidance. Clinical examination, Visual analogue scale of pain, Shoulder Pain and Disability Index (SPADI), and shoulder ultrasound were done before and at 8th week after injection. ResultsFollow up assessment showed statistically significant improvement in L-GF group as regards active flexion & active and passive internal rotation and extension, SPADI-Disability scale, VAS of pain as well as thickness of the supraspinatus tendon by US. Concerning painful arc, regression analysis has shown that placebo group is about 30 times more than the L-GF group to get painful arc at follow up. On the other hand, both groups showed statistically significant improvement regarding SPADI-Pain scale and SPADI-Total as well as passive flexion & abduction (still mean value of abduction was significantly higher in LG-F group). ConclusionsL-GF injection in patients with SIS has resulted in significant improvement as regards pain and disability according to the improvement in shoulder range of movement, painful arc sign, VAS, SPADI, as well as significant reduction in the thickness of the supraspinatus tendon as measured by ultrasound compared to the saline group. Trial registration: Identification number is NCT04330027, date of first registration (01/04/2020)Unique on 21/11/ 2019, Protocol ID: 0106178,