Myofascial Pain Syndrome (Upper Trapezius)
Conditions
Keywords
Myofascial Pain Syndrome, Dry Needling, Lidocaine Injection, Ozone Therapy, Ultrasonography, Trigger Points, Neck Pain
Brief summary
Prospective, assessor-blinded, randomized controlled trial comparing ultrasound-guided dry needling, lidocaine injection, and oxygen-ozone injection in patients with myofascial pain syndrome (MPS) of the upper trapezius muscle. 76 participants received weekly injections/needling for 3 sessions plus a standardized home exercise program, with clinical (pain, function, sleep, quality of life) and ultrasonographic (tissue imaging, blood flow waveform) outcomes assessed at baseline, Week 4, and Week 12.
Detailed description
Design: Prospective, assessor-blinded RCT Randomization: Computer-generated block randomization (block size = 6), sequentially numbered opaque sealed envelopes Blinding: Single-blind (outcome assessors blinded); participant blinding not feasible due to nature of interventions All procedures performed by a single physiatrist (\>10 years experience), ultrasound-guided, aseptic technique
Interventions
DEVICEDru Needling
Participants received ultrasound-guided dry needling of the upper trapezius trigger point, performed with a filiform needle using multidirectional technique until a local twitch response was elicited, without administration of any substance. Sessions were performed once weekly for three consecutive weeks, combined with a standardized home exercise program
DRUGLidocaine Injection (1%, 2 mL)
Participants received ultrasound-guided injection of 2 mL of 1% lidocaine directly into the upper trapezius trigger point, once weekly for three consecutive weeks, combined with a standardized home exercise program
DRUGOxygen-Ozone Injection (10 μg/mL, 5 mL)
Participants received ultrasound-guided injection of 5 mL oxygen-ozone mixture (10 μg/mL) into the upper trapezius trigger point, once weekly for three consecutive weeks, combined with a standardized home exercise program
Sponsors
Derince Training and Research Hospital
Sivas Numune Hospital
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This was a single-blind study in which outcome assessors were blinded to group allocation. Due to the nature of the interventions (dry needling, lidocaine injection, and oxygen-ozone injection), blinding of participants and treating clinicians was not feasible. However, all clinical evaluations and statistical analyses were conducted by investigators who were unaware of treatment assignment, in order to minimize assessment and analysis bias
Intervention model description
"Participants diagnosed with myofascial pain syndrome of the upper trapezius were randomly allocated in a 1:1:1 ratio to one of three parallel treatment arms - ultrasound-guided dry needling, lidocaine injection, or oxygen-ozone injection - using computer-generated block randomization (block size = 6) with allocation concealment via sequentially numbered, opaque, sealed envelopes. Each arm received three weekly sessions of the assigned intervention in addition to a standardized home exercise program, with no crossover between arms."
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years * Neck pain of at least 3 months' duration * Diagnosis of myofascial pain syndrome (MPS) according to the Simons and Travell criteria * At least one active trigger point and/or palpable taut band within the upper trapezius muscle * Reproduction of typical pain upon digital compression of the trigger point
Exclusion criteria
* Cervical radiculopathy or myelopathy * Advanced degenerative cervical spine disease * History of neck trauma or surgery within the previous year * Prior injection into the trapezius muscle within the last 3 months * Systemic conditions, including fibromyalgia, rheumatoid arthritis, polyneuropathy, coagulopathy, malignant hypertension, Graves' disease, or severe thrombocytopenia (platelet count \<50,000/µL) * Cognitive impairment * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (Visual Analog Scale, VAS) | Baseline, Week 4, and Week 12 | "Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index (NDI) | Baseline, Week 4, and Week 12 | "Functional status was evaluated using the Neck Disability Index, a 10-item questionnaire with scores ranging from 0 to 50, where higher scores indicate greater disability." |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, Week 4, and Week 12 | "Sleep quality was assessed using the Pittsburgh Sleep Quality Index, with higher scores reflecting poorer sleep quality." |
| Short Form-36 (SF-36) | Baseline, Week 4, and Week 12 | "Quality of life was evaluated using the Short Form-36, comprising eight subdomains representing physical and mental health, with higher scores indicating better health status." |
| Tissue Imaging Score (TIS) | Baseline, Week 4, and Week 12 | "Ultrasonographic tissue imaging score assessed via grayscale ultrasonography to evaluate echogenicity and structural characteristics of the trigger point muscle segment; scored 0 (normal homogeneous structure), 1 (single focal hypoechoic area), or 2 (multiple hypoechoic nodules)." |
| Blood Flow Waveform Score (BFS) | Baseline, Week 4, and Week 12 | "Doppler ultrasonographic assessment of microcirculation around the trigger point, calculated as the resistive index (RI = \[peak systolic velocity - end-diastolic velocity\] / peak systolic velocity); an RI of 1 indicates absence of diastolic flow, while RI \>1 indicates reversed diastolic flow and increased vascular resistance." |
Countries
Turkey (Türkiye)
Outcome results
None listed