NCT07547605 PRP vs PRP+Betamethasone vs Betamethasone Injection for Upper Trapezius Myofascial Pain
| NCT ID | NCT07547605 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Kyrenia |
| Condition | Myofascial Pain Dysfunction Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2026-05-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07547605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Myofascial Pain Dysfunction Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07547605 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07547605 currently recruiting?
Yes, NCT07547605 is actively recruiting participants. Contact the research team at utkugrhn@gmail.com for enrollment information.
Where is the NCT07547605 trial being conducted?
This trial is being conducted at Kyrenia, Cyprus, Kyrenia, Cyprus.
Who is sponsoring the NCT07547605 clinical trial?
NCT07547605 is sponsored by University of Kyrenia. The trial plans to enroll 150 participants.