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

NCT07547605 | Not Yet Recruiting Phase 4

• 1 other identifier: ETK-26/GL-0046
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

platelet-rich plasma; PRP; betamethasone; trigger point injection; myofascial pain syndrome; trapezius; randomized controlled trial; pressure pain threshold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Visual Analog Scale (VAS) Pain Score at 6 months

  Baseline to 6 months

• Pressure Pain Threshold (PPT)

  Baseline, week 1, week 4, month 3, month 6

• Cervical Range of Motion (ROM

  Baseline, week 4, month 3, month 6

• Rescue Analgesic Consumption

  Through 6 months

• Recurrence Rate

  6 months

Study Arms (3)

PRP Trigger Point Injection

EXPERIMENTAL

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)

Combined PRP and Betamethasone Injection

EXPERIMENTAL

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

Betamethasone Trigger Point Injection

ACTIVE COMPARATOR

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)

Interventions

Autologous Platelet-Rich Plasma (PRP) OTHER

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

PRP Trigger Point Injection

PRP plus Betamethasone DRUG

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

Combined PRP and Betamethasone Injection

Betamethasone (Diprospan) DRUG

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.

Betamethasone Trigger Point Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kyrenia: lead

Study Sites (1)

Dr. Suat Gunsel University of Kyrenia Hospital

Kyrenia, Keryneia, 6000, Cyprus

Location

MeSH Terms

Conditions

Fibromyalgia; Myofascial Pain Syndromes

Interventions

Betamethasone; betamethasone dipropionate, betamethasone sodium phosphate drug combination

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Utku Gurhan, md

CONTACT

+905391126898; utkugrhn@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to treatment allocation; all injections appear identical in volume (3 mL) and technique. The outcomes assessor (who performs VAS, PPT, and ROM measurements) is a separate physician blinded to group assignment and not present during injections. The injecting investigator is unblinded due to the technical requirement of PRP preparation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopedic Surgeon

Model Details: Three parallel arms with 1:1:1 allocation ratio. Block randomization (block size 6) using computer-generated sequence with sealed opaque envelopes. All groups receive equal injection volume (3 mL) to control for volume confounding.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CY (1)