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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Betamethasone (Diprospan) (Drug)
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.
干预措施: Autologous Platelet-Rich Plasma (PRP) (Other)
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.
干预措施: PRP plus Betamethasone (Drug)
研究者
Utku Gürhan
Assistant Professor, Orthopedic Surgeon
University of Kyrenia