Myofascial Pain Syndrome (Upper Trapezius)USDLO-MPSNCT07738783
Ultrasound-Guided Dry Needling, Lidocaine Injection, and Oxygen-Ozone Injection for Myofascial Pain Syndrome
A study testing Dry Needling, Lidocaine Injection (1%, 2 mL) and Oxygen-Ozone Injection (10 μg/mL, 5 mL) in people with Myofascial Pain Syndrome (Upper Trapezius), run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Prospective, assessor-blinded, three-arm 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain Syndrome (Upper Trapezius)
- What is being tested?
- Dry Needling, Lidocaine Injection (1%, 2 mL) and Oxygen-Ozone Injection (10 μg/mL, 5 mL)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2025to 29 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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 myofascial trigger point in the upper trapezius muscle, defined by the concurrent presence of all of the following: (1) a palpable taut band, (2) a hypersensitive tender spot within the taut band, and (3) reproduction of the patient's familiar pain on digital compression. A taut band alone was not sufficient for inclusion.
Who cannot join
- 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
- Relevant systemic conditions, including fibromyalgia, rheumatoid arthritis, polyneuropathy, malignant hypertension, coagulopathy, or severe thrombocytopenia (platelet count <50,000/µL)
- Anticoagulant therapy
Show all 10Show fewer
- Contraindications to oxygen-ozone injection: glucose-6-phosphate dehydrogenase (G6PD) deficiency or uncontrolled hyperthyroidism (including Graves' disease)
- Known allergy to local anesthetics
- Cognitive impairment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Training and Research Hospital, University of Health Sciences
Kocaeli, Derince, 41300
About this study
Official title: Ultrasound-Guided Dry Needling, Lidocaine Injection, and Oxygen-Ozone Injection for Myofascial Pain Syndrome: Clinical and Ultrasonographic Outcomes of a Prospective Randomized Controlled Trial
Prospective, assessor-blinded, three-arm 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. A total of 81 participants were randomized (27 per arm) to receive the assigned intervention once weekly for 3 sessions plus a standardized home exercise program; 76 participants completed follow-up and were analyzed (dry needling, n=25; lidocaine, n=25; oxygen-ozone, n=26). Clinical (pain, function, sleep, quality of life) and ultrasonographic (tissue imaging, blood flow waveform) outcomes were assessed at baseline, Week 4, and Week 12.
Read the detailed description
Design: Prospective, three-arm, parallel-group randomized controlled trial with blinded outcome assessment and statistical analysis, conducted between June 2025 and August 2026.
Randomization: Computer-generated block randomization (1:1:1; block size = 6, with a final block of 3); allocation concealment with sequentially numbered, sealed, opaque envelopes. Of 110 patients screened, 81 were randomized (27 per group); 5 participants discontinued before completing the three treatment sessions, and 76 completed follow-up and were analyzed.
Blinding: Clinical and ultrasonographic outcomes were assessed by a separate physiatrist (10 years of experience in musculoskeletal ultrasonography) who was not involved in the interventions and was blinded to group allocation. Statistical analyses were performed on a coded dataset by an investigator blinded to group allocation. Blinding of participants and the interventionist was not feasible because of the nature of the interventions.
Interventions: All procedures were performed under real-time ultrasound guidance (GE LOGIQ P5, 4-15 MHz linear probe) and aseptic conditions by a single physiatrist and algologist with 15 years of experience in musculoskeletal ultrasonography, using a 40-mm, 27-gauge needle in all groups. In each patient, a single active trigger point (the most painful one, on the more symptomatic side) was treated unilaterally once weekly for three sessions. All participants performed a standardized daily home exercise program; analgesics, nonsteroidal anti-inflammatory drugs, and other treatments were not permitted during the study.
- Being tested
- Dry Needling, Lidocaine Injection (1%, 2 mL), Oxygen-Ozone Injection (10 μg/mL, 5 mL)
- Keywords
- Myofascial Pain Syndrome, Dry Needling, Lidocaine Injection, Ozone Therapy, Ultrasonography, Trigger Points, Neck Pain
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
Ultrasound-guided dry needling of a single active upper trapezius trigger point using a 40-mm, 27-gauge needle with the fast-in, fast-out multidirectional technique (approximately 20 insertions over approximately 30 seconds) to elicit local twitch responses, continued until no further local twitch responses could be elicited. No substance was injected. Once weekly for three sessions, combined with a standardized home exercise program.
Lidocaine Injection (1%, 2 mL)Drug
Ultrasound-guided injection of 2 mL of 1% lidocaine (1 mL of 2% lidocaine hydrochloride diluted with 1 mL of 0.9% sodium chloride immediately before injection) into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle. Local twitch responses were intentionally elicited with the same multidirectional technique used in the dry needling group, and the injectate was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program.
Oxygen-Ozone Injection (10 μg/mL, 5 mL)Drug
Ultrasound-guided injection of 5 mL of an oxygen-ozone mixture (ozone concentration 10 μg/mL, produced from medical-grade oxygen with a calibrated medical ozone generator and injected within 30 seconds of withdrawal) into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle. Local twitch responses were intentionally elicited with the same multidirectional technique used in the dry needling group, and the mixture was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Active comparator | Participants received ultrasound-guided dry needling of a single active upper trapezius trigger point using a 40-mm, 27-gauge needle with the fast-in, fast-out multidirectional technique to elicit local twitch responses, without injection of any substance. Once weekly for three sessions, combined with a standardized home exercise program. Receives: Device: Dry Needling |
| Lidocaine Injection | Active comparator | Participants received ultrasound-guided injection of 2 mL of 1% lidocaine into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle; local twitch responses were intentionally elicited with the same multidirectional technique as in the dry needling group, and the injectate was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program. Receives: Drug: Lidocaine Injection (1%, 2 mL) |
| Oxygen-Ozone Injection | Active comparator | Participants received ultrasound-guided injection of 5 mL of an oxygen-ozone mixture (ozone concentration 10 μg/mL) into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle; local twitch responses were intentionally elicited with the same multidirectional technique as in the dry needling group, and the mixture was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program. Receives: Drug: Oxygen-Ozone Injection (10 μg/mL, 5 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)."
Measured: Baseline, Week 4, and Week 12
Secondary outcomes (5)
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."
Measured: Baseline, Week 4, and Week 12
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality assessed with the Pittsburgh Sleep Quality Index (PSQI). Global score range 0-21; higher scores indicate poorer sleep quality (scores >5 indicate poor sleep).
Measured: Baseline, Week 4, and Week 12
Short Form-36 (SF-36)
Health-related quality of life assessed with the Short Form-36 Health Survey (SF-36), reported for its eight domains (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health). Each domain is scored 0-100; higher scores indicate better health status.
Measured: 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)."
Measured: Baseline, Week 4, and Week 12
Blood Flow Waveform Score (BFS)
Ordinal Doppler blood flow waveform score (BFS, 0-2) of the small intramuscular arterial branch closest to the trigger point site, based on pulsed-wave Doppler and the resistive index (RI = [peak systolic velocity - end-diastolic velocity] / peak systolic velocity): 0 = normal resting muscle arterial flow without diastolic flow (RI = 1); 1 = increased diastolic flow indicating reduced vascular bed resistance (RI < 1); 2 = high-resistance waveform with retrograde (negative) diastolic flow (RI > 1). Higher scores indicate a more abnormal waveform.
Measured: Baseline, Week 4, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start17 Jun 2025
- Primary completion29 Aug 2026
- Study completion29 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome (Upper Trapezius)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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."
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sivas Numune Hospital, Dokuz Eylul University
- Responsible party
- Principal investigator, İlhan Celil Özbek, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738783
- Sponsor's protocol ID
- 97/2025
- Acronym
- USDLO-MPS
- Status last verified
- Nov 2026
- First submitted
- 28 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Dry Needling, Lidocaine Injection, and Oxygen-Ozone Injection for Myofascial Pain Syndrome: Clinical and Ultrasonographic Outcomes of a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07738783
- Acronym / sponsor ID
- USDLO-MPS / 97/2025
- Keywords
- Myofascial Pain Syndrome, Dry Needling, Lidocaine Injection, Ozone Therapy, Ultrasonography, Trigger Points, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Collaborators
- Sivas Numune Hospital, Dokuz Eylul University
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 29 Aug 2026 (actual)
- Study completion
- 29 Aug 2026 (actual)
- First posted
- 31 Jul 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.
Prospective, assessor-blinded, three-arm 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. A total of 81 participants were randomized (27 per arm) to receive the assigned intervention once weekly for 3 sessions plus a standardized home exercise program; 76 participants completed follow-up and were analyzed (dry needling, n=25; lidocaine, n=25; oxygen-ozone, n=26). Clinical (pain, function, sleep, quality of life) and ultrasonographic (tissue imaging, blood flow waveform) outcomes were assessed at baseline, Week 4, and Week 12.
Detailed description
Design: Prospective, three-arm, parallel-group randomized controlled trial with blinded outcome assessment and statistical analysis, conducted between June 2025 and August 2026.
Randomization: Computer-generated block randomization (1:1:1; block size = 6, with a final block of 3); allocation concealment with sequentially numbered, sealed, opaque envelopes. Of 110 patients screened, 81 were randomized (27 per group); 5 participants discontinued before completing the three treatment sessions, and 76 completed follow-up and were analyzed.
Blinding: Clinical and ultrasonographic outcomes were assessed by a separate physiatrist (10 years of experience in musculoskeletal ultrasonography) who was not involved in the interventions and was blinded to group allocation. Statistical analyses were performed on a coded dataset by an investigator blinded to group allocation. Blinding of participants and the interventionist was not feasible because of the nature of the interventions.
Interventions: All procedures were performed under real-time ultrasound guidance (GE LOGIQ P5, 4-15 MHz linear probe) and aseptic conditions by a single physiatrist and algologist with 15 years of experience in musculoskeletal ultrasonography, using a 40-mm, 27-gauge needle in all groups. In each patient, a single active trigger point (the most painful one, on the more symptomatic side) was treated unilaterally once weekly for three sessions. All participants performed a standardized daily home exercise program; analgesics, nonsteroidal anti-inflammatory drugs, and other treatments were not permitted during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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."
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Active comparator | Device: Dry NeedlingParticipants received ultrasound-guided dry needling of a single active upper trapezius trigger point using a 40-mm, 27-gauge needle with the fast-in, fast-out multidirectional technique to elicit local twitch responses, without injection of any substance. Once weekly for three sessions, combined with a standardized home exercise program. |
| Lidocaine Injection | Active comparator | Drug: Lidocaine Injection (1%, 2 mL)Participants received ultrasound-guided injection of 2 mL of 1% lidocaine into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle; local twitch responses were intentionally elicited with the same multidirectional technique as in the dry needling group, and the injectate was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program. |
| Oxygen-Ozone Injection | Active comparator | Drug: Oxygen-Ozone Injection (10 μg/mL, 5 mL)Participants received ultrasound-guided injection of 5 mL of an oxygen-ozone mixture (ozone concentration 10 μg/mL) into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle; local twitch responses were intentionally elicited with the same multidirectional technique as in the dry needling group, and the mixture was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 myofascial trigger point in the upper trapezius muscle, defined by the concurrent presence of all of the following: (1) a palpable taut band, (2) a hypersensitive tender spot within the taut band, and (3) reproduction of the patient's familiar pain on digital compression. A taut band alone was not sufficient for inclusion.
Key exclusion criteria (10 listed)
- 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
- Relevant systemic conditions, including fibromyalgia, rheumatoid arthritis, polyneuropathy, malignant hypertension, coagulopathy, or severe thrombocytopenia (platelet count <50,000/µL)
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 |
|---|---|---|
| Dry NeedlingUltrasound-guided dry needling of a single active upper trapezius trigger point using a 40-mm, 27-gauge needle with the fast-in, fast-out multidirectional technique (approximately 20 insertions over approximately 30 seconds) to elicit local twitch responses, continued until no further local twitch responses could be elicited. No substance was injected. Once weekly for three sessions, combined with a standardized home exercise program. | Device | Dry Needling |
| Lidocaine Injection (1%, 2 mL)Ultrasound-guided injection of 2 mL of 1% lidocaine (1 mL of 2% lidocaine hydrochloride diluted with 1 mL of 0.9% sodium chloride immediately before injection) into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle. Local twitch responses were intentionally elicited with the same multidirectional technique used in the dry needling group, and the injectate was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program. | Drug | Lidocaine Injection |
| Oxygen-Ozone Injection (10 μg/mL, 5 mL)Ultrasound-guided injection of 5 mL of an oxygen-ozone mixture (ozone concentration 10 μg/mL, produced from medical-grade oxygen with a calibrated medical ozone generator and injected within 30 seconds of withdrawal) into a single active upper trapezius trigger point using a 40-mm, 27-gauge needle. Local twitch responses were intentionally elicited with the same multidirectional technique used in the dry needling group, and the mixture was distributed in a fan-shaped manner within the trigger point. Once weekly for three sessions, combined with a standardized home exercise program. | Drug | Oxygen-Ozone Injection |
Primary outcome
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)."
5 secondary outcomes
Neck Disability Index (NDI)
Time frame: Baseline, Week 4, and Week 12
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Week 4, and Week 12
Short Form-36 (SF-36)
Time frame: Baseline, Week 4, and Week 12
Tissue Imaging Score (TIS)
Time frame: Baseline, Week 4, and Week 12
Blood Flow Waveform Score (BFS)
Time frame: Baseline, Week 4, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling, Lidocaine Injection (1%, 2 mL) and Oxygen-Ozone Injection (10 μg/mL, 5 mL) in people with Myofascial Pain Syndrome (Upper Trapezius), run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Visual Analog Scale, VAS) (time frame: Baseline, Week 4, and Week 12). 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 4 Nov 2026.