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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Kyrenia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 65 years

Presentation to the Orthopedics and Traumatology outpatient clinic with neck and/or shoulder pain

Presence of a taut band

Local tenderness

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autologous Platelet-Rich Plasma (PRP)

    Other intervention

    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 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

  • 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.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: PRP Trigger Point InjectionExperimental treatment 1 intervention
Group B: Combined PRP and Betamethasone InjectionExperimental treatment 1 intervention
Group C: Betamethasone Trigger Point InjectionActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline to 3 months

Secondary outcomes

1

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.

Time frame
Baseline to 6 months
2

Pressure Pain Threshold (PPT)

Measured by digital algometer (kg/cm²) directly over the active trigger point. Mean of 3 consecutive measurements by blinded evaluator.

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

Cervical Range of Motion (ROM

Flexion, extension, lateral flexion, and rotation measured in degrees using a digital goniometer by blinded evaluator.

Time frame
Baseline, week 4, month 3, month 6
4

Rescue Analgesic Consumption

Number of paracetamol 500 mg tablets consumed per week recorded by patient diary.

Time frame
Through 6 months

Other outcomes

Sponsors and contacts

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