Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506613254896 Date of Registration: 10/06/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A study comparing platelet-rich plasma and saline injections for chronic tenosynovitis: impact on pain, function, and healing over 3 months
Official scientific title Time-Dependent Growth Factor Kinetics, Platelet Concentration, and Clinical Outcomes Following Platelet-Rich Plasma Versus Saline Injection in Chronic Tenosynovitis: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Chronic tenosynovitis is a common musculoskeletal condition characterized by persistent inflammation and thickening of the tendon sheath, often resulting in pain and functional impairment. Platelet-rich plasma (PRP) has emerged as a regenerative therapy due to its high concentration of growth factors that may promote healing and reduce inflammation. However, the temporal dynamics of these growth factors after PRP administration and their correlation with clinical outcomes remain poorly defined. This randomized controlled trial aims to compare non-activated PRP with saline injection in patients with chronic tenosynovitis. The study evaluates time-dependent changes in key PRP-derived growth factors (VEGF, PDGF-AB, EGF, TGF-β), platelet concentration, and their association with clinical improvements in pain, function, and tendon sheath thickness over a 3-month follow-up period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2024
Actual trial start date 01/07/2024
Anticipated date of last follow up 31/01/2025
Actual Last follow-up date 31/01/2025
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group PRP injection group Single ultrasound-guided injection of 4-6 mL PRP Single administration with 3-month follow-up Autologous PRP prepared via double centrifugation (1000×g then 2000×g) to achieve 4-5× platelet concentration (1030±140 ×10³/µL). Injected under ultrasound guidance into affected tendon sheath. Patients avoided NSAIDs/strenuous activity for 48 hours post-injection. 25
Control Group saline injection group Single ultrasound-guided injection of 4-6 mL saline Single administration with 3-month follow-up Placebo injection of sterile saline (0.9% NaCl) administered identically to PRP group (same volume, ultrasound guidance, and post-injection protocols) 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Clinical Diagnosis: Persistent symptoms (>3 months) of chronic tenosynovitis (e.g., pain on tendon gliding, palpable crepitus, or visible swelling) Imaging Confirmation: Ultrasound or MRI showing: Tendon sheath thickening >2 mm OR Synovial fluid accumulation Failed Conservative Therapy: ≥3 months of standardized treatment including: Regular NSAID use Immobilization (splinting) ≥6 supervised physical therapy sessions Baseline Platelet Count: ≥150 × 10³/µL (to ensure adequate PRP preparation) Age Range: 18–70 years Systemic diseases affecting tissue healing (e.g., uncontrolled diabetes with HbA1c >7%, autoimmune disorders) Use of anticoagulants (warfarin, DOACs) or systemic NSAIDs within 48 hours prior to intervention Local infection or malignancy at the treatment site Pregnancy (due to hemodilution effects and unknown PRP safety) Heavy smoking (>10 cigarettes/day or ≥10 pack-year history) Hemoglobin <10 g/dL or platelet count <150 × 10³/μL Prior corticosteroid injection in the affected tendon sheath within 3 months Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/04/2024 Scientific Research Ethics Committee of Kafrelsheikh University
Ethics Committee Address
Street address City Postal code Country
Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City Kafr El-Sheikh 43511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Temporal pattern of growth factor release (VEGF, PDGF-AB, EGF, TGF-β) over 1 month post-PRP administration in the PRP group. 1 hour post-injection 8 hours post-injection Day 1 Day 3 Day 7 Day 14 1 month
Secondary Outcome Pain Reduction (VAS Score) -Time Points: Baseline, Day 7, Day 14, 1 month, 3 months Functional Improvement (WOMAC Score, adapted for tenosynovitis) -Time Points: Baseline, Day 7, Day 14, 1 month, 3 months Upper Limb Function (DASH Score) -Time Points: Baseline, 1 month, 3 months Tendon Sheath Thickness Reduction (Ultrasound) -Time Points: Baseline, 1 month, 3 months Clinical Responder Rate -Definition: ≥30% reduction in tendon sheath thickness AND ≥20 mm VAS reduction -Time Points: 1 month, 3 months Adverse Events -Time Points: Continuously monitored, formally recorded at 1 month and 3 months Baseline, Day 7, Day 14, 1 month, 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospital Egypt Kafrelsheikh, Egypt Kafrelsheikh 22516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amira Ahmed Othman Suez University Suez 44511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kafr ElSheikh University Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City Kafr ElSheikh 43511 Egypt University
Secondary Sponsor Suez University Suez Suez 44511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asmaa E Hassan Asmaa_embarak@med.kfs.edu.eg 00201002719185 Kafr Elsheikh
City Postal code Country Position/Affiliation
Kafr Elsheikh 43511 Egypt Professor of Clinical Pathology.
Role Name Email Phone Street address
Public Enquiries Amira Othman Amira.Othman@med.suezuni.edu.eg +010032508097 Suez
City Postal code Country Position/Affiliation
Suez 43511 Egypt Lecturer of Internal Medicine
Role Name Email Phone Street address
Scientific Enquiries Rasha Elgamal Raafatelatfy@yahoo.com 00201021151536 Suez
City Postal code Country Position/Affiliation
Suez 43511 Egypt Lecturer of clinical Pathology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (including demographics, clinical outcomes, growth factor levels, and adverse events) will be made available upon reasonable request to qualified researchers, starting 6 months after publication of the primary results. Data will be accessible for 5 years following sharing initiation. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol De-identified data will become available starting 6 months after primary publication and remain accessible for 5 years.Start: 6 months post-publication and End: 5 years after sharing begins Scientific Review Requests must include a methodologically sound research proposal with: Clear objectives/hypotheses Statistical analysis plan Ethical approval proof (if applicable) Institutional Approval Approved by Kafrelsheikh University Ethics Committee Signed data use agreement prohibiting re-identification or commercial use Qualified Researchers Academic/clinical researchers with: Institutional affiliation Proven expertise in musculoskeletal research (e.g., prior publications) Data Format Shared via password-protected repository (e.g., Figshare, institutional server) Anonymized per GDPR/HIPAA standards (removing all direct identifiers) Publication Commitment Recipients must: Cite the original study Share results with the primary investigators prior to publication
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/06/2025 Thank you for your comment regarding our submitted ethics approval letter. We would like to clarify that the uploaded letter is the only approval issued by the Scientific Research Ethics Committee of Kafrelsheikh University for this study. The term "Final approval" is part of the standard template used by the committee for all studies, and it does not indicate a secondary or extension approval. Importantly, this document represents the initial and official ethics approval for the study protocol, and was granted before the start of any participant enrollment or data collection. No separate or earlier version exists. Please let us know if any further clarification or supporting documentation is needed. TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2025, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2025, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/06/2025 PACTR Admin TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2025, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2024, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 03/06/2025 Thank you for your comment regarding our submitted ethics approval letter. We would like to clarify that the uploaded letter is the only approval issued by the Scientific Research Ethics Committee of Kafrelsheikh University for this study. The term "Final approval" is part of the standard template used by the committee for all studies, and it does not indicate a secondary or extension approval. Importantly, this document represents the initial and official ethics approval for the study protocol, and was granted before the start of any participant enrollment or data collection. No separate or earlier version exists. Please let us know if any further clarification or supporting documentation is needed, Kind regards.. TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2025, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2025, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 06/06/2025 Thank you for your follow-up. We would like to confirm that the ethical approval for our study was granted by the Scientific Research Ethics Committee of Kafrelsheikh University on 28 April 2024. The updated approval letter reflecting the correct date has now been provided and uploaded. Accordingly, the trial began on 01 July 2024 and completed follow-up on 31 January 2025, in full compliance with ethical requirements. TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2025, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf TRUE, Scientific Research Ethics Committee of Kafrelsheikh University, Kafr El-Sheikh University, El-Gish Road, Kafr El-Sheikh City, Kafr El-Sheikh, 43511, Egypt, , 28 Apr 2025, 00201003258097, medical_research@kfs.edu.eg, 34788_31940_4737.pdf