NCT04330027

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 9, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 30, 2020

Last Update Submit

July 7, 2020

Conditions

Shoulder Impingement Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Growth factors

EXPERIMENTAL

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

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.

Other: Saline

Interventions

Growth factorsBIOLOGICAL

A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma

Growth factors
SalineOTHER

0.9% Sodium Chloride

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University Hospitals

Alexandria, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36721157DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Intercellular Signaling Peptides and ProteinsSodium Chloride

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jailan Noureldin

    Alexandria University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jailan Noureldin

CONTACT

00201008387898jailan_ashraf@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

September 1, 2020

Primary Completion

April 1, 2021

Study Completion

June 1, 2021

Last Updated

July 9, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)