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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
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
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
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
Derince Training and Research Hospital, University of Health Sciences
Kocaeli, Derince, Turkey (Türkiye)
Pain Intensity (Visual Analog Scale, VAS)
"Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)."
Time frame: Baseline, Week 4, and Week 12
Neck Disability Index (NDI)
"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."
Time frame: Baseline, Week 4, and Week 12
Pittsburgh Sleep Quality Index (PSQI)
"Sleep quality was assessed using the Pittsburgh Sleep Quality Index, with higher scores reflecting poorer sleep quality."
Time frame: Baseline, Week 4, and Week 12
Short Form-36 (SF-36)
"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."
Time frame: Baseline, Week 4, and Week 12
Tissue Imaging Score (TIS)
"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)."
Time frame: Baseline, Week 4, and Week 12
Blood Flow Waveform Score (BFS)
"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."
Time frame: Baseline, Week 4, and Week 12
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