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A study comparing platelet-rich plasma and saline injections for chronic tenosynovitis: impact on pain, function, and healing over 3 months

Time-Dependent Growth Factor Kinetics, Platelet Concentration, and Clinical Outcomes Following Platelet-Rich Plasma Versus Saline Injection in Chronic Tenosynovitis: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202506613254896
Enrollment
50
Registered
2025-06-10
Start date
2024-07-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopaedics

Interventions

PRP injection group
saline injection group

Sponsors

Kafr ElSheikh University
Lead Sponsor
Suez University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Temporal pattern of growth factor release (VEGF, PDGF-AB, EGF, TGF-ß) over 1 month post-PRP administration in the PRP group.

Secondary

MeasureTime frame
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

Countries

Egypt

Contacts

Public ContactAmira Othman

Lecturer of Internal Medicine

Amira.Othman@med.suezuni.edu.eg+010032508097

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026