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NCT Number: NCT07738783

Ultrasound-Guided Dry Needling, Lidocaine Injection, and Oxygen-Ozone Therapy for Myofascial Pain Syndrome

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.

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Key information

Conditions

Myofascial Pain Syndrome (Upper Trapezius) Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Derince Training and Research Hospital, University of Health Sciences

Kocaeli, Derince, 41300, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dru Needling

Device

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

Lidocaine Injection (1%, 2 mL)

Drug

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

Oxygen-Ozone Injection (10 μg/mL, 5 mL)

Drug

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

Primary outcomes

  1. Pain Intensity (Visual Analog Scale, VAS)

    Time frame: 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 outcomes

  1. Neck Disability Index (NDI)

    Time frame: 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."

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline, Week 4, and Week 12

    "Sleep quality was assessed using the Pittsburgh Sleep Quality Index, with higher scores reflecting poorer sleep quality."

  3. Short Form-36 (SF-36)

    Time frame: 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."

  4. Tissue Imaging Score (TIS)

    Time frame: 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)."

  5. Blood Flow Waveform Score (BFS)

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Collaborators

  • Dokuz Eylul University
  • Sivas Numune Hospital

Registry information

Official study title

Ultrasound-Guided Dry Needling, Lidocaine Injection, and Oxygen-Ozone Therapy for Myofascial Pain Syndrome: Clinical and Ultrasonographic Outcomes of a Prospective Randomized Controlled Trial

Acronym: USDLO-MPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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