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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth factors | Experimental | Patients in this group will receive one lyophilized Growth Factors injection supplied as a powder in a tightly sealed container. |
|
| Saline | Placebo Comparator | Patients in this group will receive an injection with equal volume of saline; i.e 2ml of 0.9% sodium chloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth factors | Biological | A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma |
|
| 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 |
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Inclusion Criteria:
Clinically:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jailan Noureldin | Contact | 00201008387898 | jailan_ashraf@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Jailan Noureldin | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University Hospitals | Recruiting | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36721157 | Derived | El-Sherif SM, Abdel-Hamid MM, Noureldin JMAM, Fahmy HM, Abdel-Naby HMA. Effectiveness of lyophilized growth factors injection for subacromial impingement syndrome: a prospective randomized double-blind placebo-controlled study. J Orthop Surg Res. 2023 Jan 31;18(1):78. doi: 10.1186/s13018-023-03548-4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 16, 2022 | |
| Reset | Jul 13, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 16, 2022 | Jul 13, 2023 |
| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| Saline | Other | 0.9% Sodium Chloride |
|
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |