Shoulder Impingement SyndromeNCT04330027
Effectiveness of Lyophilized Growth Factors for Subacromial Impingement
A study testing Growth factors and Saline in people with Shoulder Impingement Syndrome, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Growth factors and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University Hospitals
Alexandria
Jailan Ashraf, 00201008387898, jailan_ashraf@outlook.com
About this study
Official title: Effectiveness of Lyophilized Growth Factors for Subacromial Impingement: Randomized Double Blind Placebo Controlled Study
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.
Read the 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.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Growth factors, Saline
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth factorsBiological
A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma
SalineOther
0.9% Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| Growth factors | Experimental | Patients in this group will receive one lyophilized Growth Factors injection supplied as a powder in a tightly sealed container. Receives: Biological: Growth factors |
| Saline | Placebo comparator | Patients in this group will receive an injection with equal volume of saline; i.e 2ml of 0.9% sodium chloride. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study startSep 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jailan Noureldin, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330027
- Sponsor's protocol ID
- 0106178
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36721157
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Lyophilized Growth Factors for Subacromial Impingement: Randomized Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04330027
- Acronym / sponsor ID
- 0106178
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth factors | Experimental | Biological: Growth factorsPatients in this group will receive one lyophilized Growth Factors injection supplied as a powder in a tightly sealed container. |
| Saline | Placebo comparator | Other: SalinePatients in this group will receive an injection with equal volume of saline; i.e 2ml of 0.9% sodium chloride. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth factorsA new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma | Biological | Growth factors |
| Saline0.9% Sodium Chloride | Other | Saline |
Primary outcome
VAS (Visual Analogue Scale)
Time frame: 8 weeks
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)
Time frame: 8 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 36721157El-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jailan Noureldin principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth factors and Saline in people with Shoulder Impingement Syndrome, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jailan Noureldin (00201008387898, jailan_ashraf@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analogue Scale) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.