Back to resultsEffectiveness of Lyophilized Growth Factors for Subacromial Impingement
Primary Purpose
Shoulder Impingement Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Growth factors
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome
Eligibility Criteria
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.
Sites / Locations
- Alexandria University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Growth factors
Saline
Arm Description
Patients in this group will receive one lyophilized Growth Factors injection supplied as a powder in a tightly sealed container.
Patients in this group will receive an injection with equal volume of saline; i.e 2ml of 0.9% sodium chloride.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04330027
Brief Title
Effectiveness of Lyophilized Growth Factors for Subacromial Impingement
Official Title
Effectiveness of Lyophilized Growth Factors for Subacromial Impingement: Randomized Double Blind Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Growth factors
Arm Type
Experimental
Arm Description
Patients in this group will receive one lyophilized Growth Factors injection supplied as a powder in a tightly sealed container.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Patients in this group will receive an injection with equal volume of saline; i.e 2ml of 0.9% sodium chloride.
Intervention Type
Biological
Intervention Name(s)
Growth factors
Intervention Description
A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
0.9% Sodium Chloride
Primary Outcome Measure Information:
Title
VAS (Visual Analogue Scale)
Description
Pain assessment scale. The minimum value is zero and the maximum value is 10. A higher score indicates a worse outcome.
Time Frame
8 weeks
Title
SPADI (Shoulder Pain and Disability Index)
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jailan Noureldin
Phone
00201008387898
Email
jailan_ashraf@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jailan Noureldin
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University Hospitals
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jailan Ashraf
Phone
00201008387898
Email
jailan_ashraf@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Lyophilized Growth Factors for Subacromial Impingement
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