Myofascial Pain Dysfunction SyndromePhase 4UMAY-RCTNCT07547605
PRP vs PRP+Betamethasone vs Betamethasone Injection for Upper Trapezius Myofascial Pain
A Phase 4 study testing Autologous Platelet-Rich Plasma (PRP), PRP plus Betamethasone and Betamethasone (Diprospan) in people with Myofascial Pain Dysfunction Syndrome and Trigger Points, Myofascial, run by University of Kyrenia at 2 sites in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Dysfunction Syndrome, Trigger Points, Myofascial, Trigger Point in Trapezius Muscle
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP), PRP plus Betamethasone and Betamethasone (Diprospan)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCyprus
- Study dates
- 15 May 2026to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- Active infection (systemic or local)
- Pregnancy or lactation
- Thrombocytopenia (platelet count < 100,000/µL)
- Malignancy
- Inability to cooperate or provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus2 sites, 2 recruiting
- Recruiting
Dr. Suat Gunsel University of Kyrenia Hospital
Kyrenia, Keryneia, 6000
Utku Gurhan, md, 05391126898, utkugrhn@gmail.com
- Recruiting
Dr. Suat Gunsel University of Kyrenia Hospital
Kyrenia, 6000
Gurhan, 05391126898, utkugrhn@gmail.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Myofascial Pain Dysfunction Syndrome, Trigger Points, Myofascial, Trigger Point in Trapezius Muscle
- Being tested
- Autologous Platelet-Rich Plasma (PRP), PRP plus Betamethasone, Betamethasone (Diprospan)
- Keywords
- platelet-rich plasma, PRP, betamethasone, trigger point injection, myofascial pain syndrome, trapezius, randomized controlled trial, pressure pain threshold
- Medical subject headings
- Fibromyalgia, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 plus BetamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Betamethasone (Diprospan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 4, month 3, month 6
Rescue Analgesic Consumption
Number of paracetamol 500 mg tablets consumed per week recorded by patient diary.
Measured: Through 6 months
Recurrence Rate
Proportion of patients whose VAS score returns to ≥50% of baseline value within 6-month follow-up.
Measured: 6 months
Patient Satisfaction
5-point Likert scale (1=very satisfied, 5=very dissatisfied) assessed by blinded evaluator.
Measured: Month 3, Month 6
Adverse Events
Incidence of injection site reactions, vasovagal syncope, systemic corticosteroid effects, and infection.
Measured: Through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 May 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Dysfunction SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kyrenia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utku Gürhan, University of Kyrenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547605
- Sponsor's protocol ID
- ETK-26/GL-0046
- Acronym
- UMAY-RCT
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07547605
- Acronym / sponsor ID
- UMAY-RCT / ETK-26/GL-0046
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of KyreniaUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRP Trigger Point Injection | Experimental | Other: Autologous Platelet-Rich Plasma (PRP)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. |
| Combined PRP and Betamethasone Injection | Experimental | Drug: PRP plus BetamethasoneSingle palpation-guided trigger point injection: 1 mL PRP + 1 mL bupivacaine 0.5% + 1 mL Diprospan (betamethasone). Total volume: 3 mL. Single session. |
| Betamethasone Trigger Point Injection | Active comparator | Drug: Betamethasone (Diprospan)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP)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 | Other | PRP Trigger Point Injection |
| PRP plus Betamethasone1 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 | Combined PRP and Betamethasone Injection |
| Betamethasone (Diprospan)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. | Drug | Betamethasone Trigger Point Injection |
Primary outcome
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline to 3 months
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.
7 secondary outcomes
Change in Visual Analog Scale (VAS) Pain Score at 6 months
Time frame: Baseline to 6 months
Pressure Pain Threshold (PPT)
Time frame: Baseline, week 1, week 4, month 3, month 6
Cervical Range of Motion (ROM
Time frame: Baseline, week 4, month 3, month 6
Rescue Analgesic Consumption
Time frame: Through 6 months
Recurrence Rate
Time frame: 6 months
Patient Satisfaction
Time frame: Month 3, Month 6
Adverse Events
Time frame: Through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Autologous Platelet-Rich Plasma (PRP), PRP plus Betamethasone and Betamethasone (Diprospan) in people with Myofascial Pain Dysfunction Syndrome and Trigger Points, Myofascial, run by University of Kyrenia at 2 sites in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Utku Gurhan, md (+905391126898, utkugrhn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Pain Score (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.