A Phase 4 interventional study of Autologous Platelet-Rich Plasma (PRP) and PRP plus Betamethasone in Myofascial Pain Dysfunction Syndrome, Trigger Points, Myofascial and Trigger Point in Trapezius Muscle, sponsored by University of Kyrenia. Recruiting at 2 sites in Cyprus. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by University of Kyrenia · Phase 4, Interventional, and Treatment
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 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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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)
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
Drug pages: Platelet rich plasma · 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
Drug page: Betamethasone dipropionate
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.
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
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
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
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
Rescue Analgesic Consumption
Number of paracetamol 500 mg tablets consumed per week recorded by patient diary.
Time frame: Through 6 months
Recurrence Rate
Proportion of patients whose VAS score returns to ≥50% of baseline value within 6-month follow-up.
Time frame: 6 months
Patient Satisfaction
5-point Likert scale (1=very satisfied, 5=very dissatisfied) assessed by blinded evaluator.
Time frame: Month 3, Month 6
Adverse Events
Incidence of injection site reactions, vasovagal syncope, systemic corticosteroid effects, and infection.
Time frame: Through 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
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Studies of the drugs tested here: Platelet rich plasma · Betamethasone
University of Kyrenia