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RECRUITING
NCT07547605
PHASE4

PRP vs PRP+Betamethasone vs Betamethasone Injection for Upper Trapezius Myofascial Pain

Sponsor: University of Kyrenia

View on ClinicalTrials.gov

Summary

Brief Summary Myofascial pain syndrome (MPS) is a common musculoskeletal condition characterized by active trigger points (TrPs), which are hypersensitive, painful nodules within taut bands of skeletal muscle. The upper trapezius muscle is one of the most frequently affected sites. Trigger point injection (TPI) is a widely used minimally invasive treatment for patients who are refractory to conservative management. Corticosteroids provide rapid anti-inflammatory effects, whereas platelet-rich plasma (PRP) has regenerative properties through growth factors that may support tissue healing. Despite their widespread use, the optimal injectate for TPI remains unclear. Additionally, the potential benefit of combining PRP with corticosteroids has not been adequately studied in upper trapezius MPS. This study is a single-center, prospective, randomized, assessor-blinded controlled trial designed to compare the clinical effectiveness of three injection protocols: (1) PRP plus bupivacaine, (2) PRP plus betamethasone plus bupivacaine, and (3) betamethasone plus bupivacaine with saline (volume-matched control). A total of 150 patients with a single active trigger point in the upper trapezius will be included. The primary outcome is pain intensity measured by the visual analog scale (VAS) at 3 months. Secondary outcomes include pressure pain threshold (PPT), cervical range of motion (ROM), rescue analgesic use, recurrence rate, and adverse events at 1 week, 4 weeks, 3 months, and 6 months. All injections are performed by the same investigator using a palpation-guided technique, and outcome assessments are conducted by a blinded evaluator.

Official title: Comparison of Platelet-Rich Plasma, Combined Platelet-Rich Plasma Plus Betamethasone, and Betamethasone Monotherapy Trigger Point Injections in Patients With Upper Trapezius Myofascial Pain Syndrome: A Prospective, Randomized, Assessor-Blind, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-05

Completion Date

2027-01

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

OTHER

Autologous Platelet-Rich Plasma (PRP)

2 mL autologous leukocyte-poor PRP prepared by double centrifugation, combined with 1 mL bupivacaine 0.5%. Single palpation-guided trigger point injection into upper trapezius. Total volume: 3 mL

DRUG

PRP plus Betamethasone

1 mL autologous LP-PRP + 1 mL Diprospan (betamethasone dipropionate 5 mg + betamethasone sodium phosphate 2 mg) + 1 mL bupivacaine 0.5%. Single palpation-guided trigger point injection. Total volume: 3 mL

DRUG

Betamethasone (Diprospan)

1 mL Diprospan (betamethasone dipropionate 5 mg + betamethasone sodium phosphate 2 mg) + 1 mL bupivacaine 0.5% + 1 mL normal saline (0.9% NaCl, volume equalization). Single palpation-guided trigger point injection. Total volume: 3 mL.

Locations (2)

Dr. Suat Gunsel University of Kyrenia Hospital

Kyrenia, Keryneia, Cyprus

Dr. Suat Gunsel University of Kyrenia Hospital

Kyrenia, Cyprus