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

NCT07738783 | Completed

• 1 other identifier: 97/2025
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndrome (Upper Trapezius)

Keywords

Myofascial Pain Syndrome; Dry Needling; Lidocaine Injection; Ozone Therapy; Ultrasonography; Trigger Points; Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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)."

  Baseline, Week 4, and Week 12

Secondary Outcomes (5)

• Neck Disability Index (NDI)

  Baseline, Week 4, and Week 12

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, Week 4, and Week 12

• Short Form-36 (SF-36)

  Baseline, Week 4, and Week 12

• Tissue Imaging Score (TIS)

  Baseline, Week 4, and Week 12

• Blood Flow Waveform Score (BFS)

  Baseline, Week 4, and Week 12

Study Arms (3)

Dry Needling

ACTIVE COMPARATOR

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

Device: Dru Needling

Lidocaine Injection

ACTIVE COMPARATOR

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

Drug: Lidocaine Injection (1%, 2 mL)

Oxygen-Ozone Injection

ACTIVE COMPARATOR

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

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

Interventions

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

Dry Needling

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

Lidocaine Injection

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

Oxygen-Ozone Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Derince Training and Research Hospital: lead
• Sivas Numune Hospital: collaborator
• Dokuz Eylul University: collaborator

Study Sites (1)

Derince Training and Research Hospital, University of Health Sciences

Kocaeli, Derince, 41300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Neck Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: "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."

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: June 17, 2025
• Primary Completion: May 22, 2026
• Study Completion: May 22, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

TU (1)