PRP vs PRP+Betamethasone vs Betamethasone Injection for Upper Trapezius Myofascial Pain (UMAY-RCT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Trigger Points, Myofascial; Myofascial Pain Dysfunction Syndrome; Trigger Point in Trapezius Muscle
• Intervention / Treatment: Other: Autologous Platelet-Rich Plasma (PRP); Drug: PRP plus Betamethasone; Drug: Betamethasone (Diprospan)

Detailed Description

Study Design

This is a single-center, prospective, three-arm randomized controlled trial. Randomization will be performed using a computer-generated block randomization method (block size: 6, allocation ratio 1:1:1) with sealed opaque envelopes. Patients and outcome assessors will be blinded to group allocation. The injecting physician will not be blinded due to the nature of PRP preparation.

Interventions

Group A (PRP group):

2 mL autologous leukocyte-poor PRP + 1 mL bupivacaine 0.5% (total 3 mL)

Group B (Combination group):

1 mL PRP + 1 mL bupivacaine 0.5% + 1 mL betamethasone (total 3 mL)

Group C (Control group):

1 mL betamethasone + 1 mL bupivacaine 0.5% + 1 mL normal saline (total 3 mL)

All groups receive equal injection volumes to avoid volume-related bias.

PRP Preparation

Ten milliliters of peripheral venous blood will be collected into a citrate-containing tube. The first centrifugation will be performed at 1500 rpm for 10 minutes, followed by a second centrifugation at 2500 rpm for 10 minutes. One milliliter of leukocyte-poor PRP will be obtained. No activator will be used. The preparation will be applied within 30 minutes. Platelet concentration and preparation parameters will be recorded.

Injection Technique

Trigger point injections will be performed using a palpation-guided technique without ultrasound assistance. A 25G needle will be inserted at approximately 30 degrees into the trigger point. Local twitch response will be documented during the procedure.

Outcome Assessments

Baseline (T0):

VAS, PPT (algometer), cervical ROM (digital goniometer)

1 week (T1): VAS, PPT, adverse events 4 weeks (T2): VAS, PPT, ROM, rescue analgesic use 3 months (T3 - Primary endpoint): VAS, PPT, ROM, rescue analgesic use, patient satisfaction 6 months (T4): VAS, PPT, ROM, recurrence evaluation, patient satisfaction Statistical Analysis

The primary analysis will be conducted using repeated measures ANOVA with Greenhouse-Geisser correction. Post hoc comparisons will be performed using Tukey HSD with Bonferroni adjustment. Intention-to-treat analysis will be applied. Missing data will be handled using multiple imputation. A per-protocol analysis will be performed as a sensitivity analysis. Recurrence rates will be analyzed using Kaplan-Meier survival analysis and log-rank testing. Statistical analyses will be performed using SPSS version 26.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Utku Gurhan, md; Phone Number: +905391126898; Email: utkugrhn@gmail.com

Study Locations

• Cyprus
  • Kyrenia, Cyprus, 6000
    • Recruiting
    • Dr. Suat Gunsel University of Kyrenia Hospital
    • Contact: Gurhan; Phone Number: 05391126898; Email: utkugrhn@gmail.com
  • Keryneia
    • Kyrenia, Keryneia, Cyprus, 6000
      • Recruiting
      • Dr. Suat Gunsel University of Kyrenia Hospital
      • Contact: Utku Gurhan, md; Phone Number: 05391126898; Email: utkugrhn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP Trigger Point Injection; Single palpation-guided trigger point injection in upper trapezius: 2 mL autologous leukocyte-poor PRP + 1 mL bupivacaine 0.5%. Total volume: 3 mL. Single session.	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
Experimental: Combined PRP and Betamethasone Injection; Single palpation-guided trigger point injection: 1 mL PRP + 1 mL bupivacaine 0.5% + 1 mL Diprospan (betamethasone). Total volume: 3 mL. Single session.	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
Active Comparator: Betamethasone Trigger Point Injection; Single palpation-guided trigger point injection: 1 mL Diprospan (betamethasone) + 1 mL bupivacaine 0.5% + 1 mL normal saline (volume equalization). Total volume: 3 mL. Single session.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) Pain Score	Pain intensity measured on a 10-cm horizontal Visual Analog Scale (0 = no pain, 10 = worst imaginable pain). Assessed by a blinded evaluator separate from the injecting physician. Minimum clinically important difference (MCID): 1.5 cm.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS) Pain Score at 6 months	Pain intensity on 10-cm horizontal VAS assessed by blinded evaluator. Long-term durability of effect.	Baseline to 6 months
Pressure Pain Threshold (PPT)	Measured by digital algometer (kg/cm²) directly over the active trigger point. Mean of 3 consecutive measurements by blinded evaluator.	Baseline, week 1, week 4, month 3, month 6
Cervical Range of Motion (ROM	Flexion, extension, lateral flexion, and rotation measured in degrees using a digital goniometer by blinded evaluator.	Baseline, week 4, month 3, month 6
Rescue Analgesic Consumption	Number of paracetamol 500 mg tablets consumed per week recorded by patient diary.	Through 6 months
Recurrence Rate	Proportion of patients whose VAS score returns to ≥50% of baseline value within 6-month follow-up.	6 months
Patient Satisfaction	5-point Likert scale (1=very satisfied, 5=very dissatisfied) assessed by blinded evaluator.	Month 3, Month 6
Adverse Events	Incidence of injection site reactions, vasovagal syncope, systemic corticosteroid effects, and infection.	Through 6 months

Collaborators and Investigators

• Sponsor: University of Kyrenia

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; myofascial pain syndrome; PRP; platelet-rich plasma; pressure pain threshold; betamethasone; trapezius; trigger point injection
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Betamethasone; betamethasone dipropionate, betamethasone sodium phosphate drug combination
• Other Study ID Numbers: ETK-26/GL-0046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No