RecruitingPhase 4NCT07547605

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

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

Sponsor

University of Kyrenia

Enrollment

150 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Trigger Point in Trapezius Muscle Myofascial Pain Dysfunction Syndrome Trigger Points, Myofascial

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria12

Age between 18 and 65 years
Presentation to the Orthopedics and Traumatology outpatient clinic with neck and/or shoulder pain
Diagnosis of upper trapezius myofascial pain syndrome based on Simons and Travell criteria, including:
Presence of a taut band
Local tenderness
Referred pain pattern
Local twitch response
Presence of a single active trigger point in the upper trapezius muscle
Symptom duration ≥ 4 weeks
Pain intensity ≥ 4 on the visual analog scale (VAS)
Inadequate response to at least 4 weeks of conservative treatment (physical therapy and/or oral analgesics)
Ability to provide written informed consent

Exclusion Criteria11

Presence of multiple active trigger points
Diagnosis of fibromyalgia according to ACR 2010 criteria
Cervical radiculopathy or myelopathy
Trigger point injection in the same region within the past 3 months
Coagulopathy or current anticoagulant or antiplatelet therapy
Known allergy or contraindication to corticosteroids, local anesthetics, or PRP components
Active infection (systemic or local)
Pregnancy or lactation
Thrombocytopenia (platelet count < 100,000/µL)
Malignancy
Inability to cooperate or provide informed consent

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Interventions

OTHERAutologous 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

DRUGPRP 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

DRUGBetamethasone (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.