Myofascial Pain of Upper Trapezius MusclePhase 4NCT07456735
Comparison of the Effectiveness of Dry Needling Versus the Combination of Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome of the Upper Trapezius Muscle: A Sham-Controlled, Randomized Clinical Trial
A Phase 4 study testing Dry Needling and Local Anesthehetic Injection in people with Myofascial Pain of Upper Trapezius Muscle, run by Emre Ata, Assoc Prof at 1 site in Turkey (Türkiye).
Trial summary
This study was designed to compare the effectiveness of three different treatment protocols in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle. A total of 90 volunteers aged between 18 and 65 years, with active trigger points identified in the upper trapezius muscle, will be included in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain of Upper Trapezius Muscle
- What is being tested?
- Dry Needling and Local Anesthehetic Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 10 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Being between 18 and 65 years of age
- Having a diagnosis of myofascial pain syndrome with at least one active trigger point in the upper trapezius muscle according to the criteria of Travell and Simons
- Having signed the informed consent form regarding the study
- Having a history of muscle pain with VAS >3 persisting for at least four weeks in the same area (upper trapezius muscle)
Who cannot join
- Having a diagnosis of cervical disc herniation, cervical radiculopathy, or myelopathy
- A history of central or peripheral nervous system disease (e.g., multiple sclerosis, stroke, peripheral neuropathy)
- Diagnosis of a major psychiatric disorder (major depression, anxiety disorder, bipolar disorder, schizophrenia) or receiving active psychiatric treatment
- Having bleeding diathesis, thrombocytopenia, or using anticoagulant/antiplatelet therapy for any reason (e.g., warfarin, clopidogrel)
- Presence of local infection at the injection site, dermatological lesions disrupting skin integrity, or signs of systemic infection
- Being pregnant or breastfeeding
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- Having undergone injection, prolotherapy, or similar interventional treatment in the upper trapezius region within the last 6 months
- Having received dry needling treatment in any region previously
- A history of orthopedic or neurosurgical surgery involving the cervical spine, shoulder, or upper trapezius muscle region within the last year
- Having a diagnosis of uncontrolled diabetes mellitus or advanced-stage chronic disease (e.g., congestive heart failure, renal failure)
- Having a diagnosis of malignancy or systemic rheumatologic disease (e.g., rheumatoid arthritis, fibromyalgia syndrome, lupus)
- Having communication difficulties, cognitive impairment, or severe visual/hearing loss that could prevent participation in the study
- Having social/logistical barriers (e.g., transportation difficulties) that would prevent regular participation in the study process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, ÜSKÜDAR, 34674
EMRE A ATA, Associate Professor, MD, +905462388649, mgorgelitf@gmail.com
About this study
Official title: Comparison of the Effectivenes of Combined Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome in Upper Trapezius Muscle
This study was designed to compare the effectiveness of three different treatment protocols in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle. A total of 90 volunteers aged between 18 and 65 years, with active trigger points identified in the upper trapezius muscle, will be included in the study. Participants will be randomly assigned to three groups:
- Group 1: Dry needling and stretching exercises
- Group 2: Dry needling following local anesthetic injection with 1% lidocaine and stretching exercises
- Group 3 (Control): Sham dry needling following local anesthetic injection with 1% lidocaine and stretching exercises
In all groups, treatment sessions will be administered at weeks 0, 1, 2, and 3; and participants will undergo clinical assessments at baseline (pre-treatment), at the end of treatment, one month after treatment completion, and three months after treatment completion. The primary outcome will be pain severity, measured using the Numeric Pain Rating Scale (NRS); secondary outcomes will include functional status evaluated with the Neck Pain and Disability Scale (NPADS) and QuickDASH, and muscle tenderness assessed by pressure pain threshold (PPT) measurement. The findings are expected to contribute scientifically to clinical practice by identifying the most effective treatment combination for managing upper trapezius myofascial pain syndrome.
Read the detailed description
Myofascial pain syndrome (MPS) is one of the most common causes of chronic pain among musculoskeletal disorders, leading to both individual workforce loss and a decrease in quality of life. The pathophysiological basis of MPS consists of hyperalgesic areas within the muscle tissue, known as "trigger points. These trigger points usually arise due to repetitive microtrauma, poor posture, or static muscle use, with the upper trapezius muscle being one of the most frequently affected muscle groups .
Dry needling (DN) induces local microtrauma within the muscle by directly and invasively stimulating the trigger points, thereby initiating local inflammation and achieving an analgesic effect. DN is thought to work by reducing muscle spasm, increasing oxygenation, and providing segmental pain inhibition \[1, 5]. On the other hand, local anesthetic injection (LAI), particularly with agents such as lidocaine, provides rapid analgesia by temporarily blocking nerve conduction when applied directly around the trigger point .
Although the combined use of DN and LAI has gained attention in recent years, comparative clinical data regarding their efficacy remain limited. Some studies in the literature have shown that LAI is more effective than DN in reducing pain , yet systematic data on the advantages of combined protocols are insufficient. Additionally, some randomized controlled trials have reported that DN provides functional improvement, while achieving similar pain scores compared to LAI.
The use of sham procedures is critically important for evaluating the true biological effect of treatment. Especially in invasive techniques like dry needling, the absence of placebo control increases the risk of misinterpreting the analgesic effect. Therefore, there is a need for methodologically robust study designs.
The present study aims to demonstrate the clinical superiority of combining DN with LAI, compared to DN alone and sham groups, in terms of both pain reduction and functional improvement. The combined approach may result in more lasting outcomes on muscle tension and function. Moreover, thanks to the comparison group with sham procedures, the true clinical efficacy of the interventions can be evaluated more objectively.
- Being tested
- Dry Needling, Sham Dry Needling, Local Anesthehetic Injection
- Keywords
- myofascial pain syndrome,trigger points,dry needling
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
Dry needling is a procedure where an acupuncture needle is penetrated to the active myofascial trigger point in a muscle, until a twitch response is gained. Patients will be lied supine and an examiner with 10 years of experience will palpate the upper trapezius muscle. Identified active myofascial trigger points will be penetrated with acupuncture needles until the twitch response is obtained.
Sham Dry NeedlingProcedure or surgery
Sham dry needling is a procedure where the needle does not penetrate to the skin or the muscle, but the tube of the needle will be contacted to the skin.
Local Anesthehetic InjectionProcedure or surgery
Local anesthetic injection is a procedure where the %1 lidocaine ( 4 cc) is injected to the myofascial trigger points. Patient will be lying supine and the examiner with 10 years of experience will palpate the trapezius muscles upper part. Identified trigger points will be penetrated by a needle and will be injected lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Local Anesthetic Injection + Sham Dry Needling Group | Sham comparator | Patients will recieve %1 Lidocaine injection to the upper trapezius muscles trigger points. They will also recieve a sham dry needling, where the needle will not penetrate to the skin but the tube of the needle will be contacted to the skin. Receives: Procedure: Sham Dry Needling; Procedure: Local Anesthehetic Injection |
| Dry Needling Group | Active comparator | This group will get 3 sessions of dry needling to the trigger points on upper trapezius muscle. Receives: Procedure: Dry Needling |
| Local Aensthetic injection + Dry Needling Group | Experimental | This group will get trigger point local anesthetic injection and 3 sessions of dry needling terapy to the trigger points on upper trapezius muscle Receives: Procedure: Dry Needling; Procedure: Local Anesthehetic Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NRS)
Numeric Pain Rating Scale (NRS): Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (the most severe pain) based on their own perception; the measurement will be conducted verbally by a qualified researcher in a calm environment
Measured: It is the change from the baseline (pre-treatment) NRS (Numeric Pain Rating Scale) score to the NRS score at the 3rd month.
Secondary outcomes (3)
Neck Pain and Disability Scale (NPADS
Neck Pain and Disability Scale (NPADS): The 20-item short form of the NPADS will be used; the researcher will ask each item using a standardized questionnaire form and record the participant's responses.
Measured: 3 months
QuickDASH
QuickDASH: The 11-item Turkish QuickDASH form will be used to assess upper extremity function and quality of life; the participant will complete the form themselves, and the researcher will provide clarification if needed.
Measured: 3 months
Pressure Pain Threshold (PPT)
Pressure Pain Threshold (PPT): Using a digital algometer (e.g., Wagner FDX Digital Force Gauge), the pressure tolerance threshold applied to the trigger point will be recorded in kg/cm² while the patient is seated in a passive position. Each measurement will be repeated three times, and the average value will be calculated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion20 Apr 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain of Upper Trapezius MuscleStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emre Ata, Assoc Prof
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emre Ata, Assoc Prof, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456735
- Sponsor's protocol ID
- SultanAbdülhamidftr2
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectivenes of Combined Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome in Upper Trapezius Muscle
- ClinicalTrials.gov ID
- NCT07456735
- Acronym / sponsor ID
- SultanAbdülhamidftr2
- Keywords
- myofascial pain syndrome,trigger points,dry needling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Emre Ata, Assoc ProfUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 6 Mar 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.
This study was designed to compare the effectiveness of three different treatment protocols in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle. A total of 90 volunteers aged between 18 and 65 years, with active trigger points identified in the upper trapezius muscle, will be included in the study. Participants will be randomly assigned to three groups:
- Group 1: Dry needling and stretching exercises
- Group 2: Dry needling following local anesthetic injection with 1% lidocaine and stretching exercises
- Group 3 (Control): Sham dry needling following local anesthetic injection with 1% lidocaine and stretching exercises
In all groups, treatment sessions will be administered at weeks 0, 1, 2, and 3; and participants will undergo clinical assessments at baseline (pre-treatment), at the end of treatment, one month after treatment completion, and three months after treatment completion. The primary outcome will be pain severity, measured using the Numeric Pain Rating Scale (NRS); secondary outcomes will include functional status evaluated with the Neck Pain and Disability Scale (NPADS) and QuickDASH, and muscle tenderness assessed by pressure pain threshold (PPT) measurement. The findings are expected to contribute scientifically to clinical practice by identifying the most effective treatment combination for managing upper trapezius myofascial pain syndrome.
Detailed description
Myofascial pain syndrome (MPS) is one of the most common causes of chronic pain among musculoskeletal disorders, leading to both individual workforce loss and a decrease in quality of life. The pathophysiological basis of MPS consists of hyperalgesic areas within the muscle tissue, known as "trigger points. These trigger points usually arise due to repetitive microtrauma, poor posture, or static muscle use, with the upper trapezius muscle being one of the most frequently affected muscle groups .
Dry needling (DN) induces local microtrauma within the muscle by directly and invasively stimulating the trigger points, thereby initiating local inflammation and achieving an analgesic effect. DN is thought to work by reducing muscle spasm, increasing oxygenation, and providing segmental pain inhibition \[1, 5]. On the other hand, local anesthetic injection (LAI), particularly with agents such as lidocaine, provides rapid analgesia by temporarily blocking nerve conduction when applied directly around the trigger point .
Although the combined use of DN and LAI has gained attention in recent years, comparative clinical data regarding their efficacy remain limited. Some studies in the literature have shown that LAI is more effective than DN in reducing pain , yet systematic data on the advantages of combined protocols are insufficient. Additionally, some randomized controlled trials have reported that DN provides functional improvement, while achieving similar pain scores compared to LAI.
The use of sham procedures is critically important for evaluating the true biological effect of treatment. Especially in invasive techniques like dry needling, the absence of placebo control increases the risk of misinterpreting the analgesic effect. Therefore, there is a need for methodologically robust study designs.
The present study aims to demonstrate the clinical superiority of combining DN with LAI, compared to DN alone and sham groups, in terms of both pain reduction and functional improvement. The combined approach may result in more lasting outcomes on muscle tension and function. Moreover, thanks to the comparison group with sham procedures, the true clinical efficacy of the interventions can be evaluated more objectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 3
| Arm | Type | Receives |
|---|---|---|
| Local Anesthetic Injection + Sham Dry Needling Group | Sham comparator | Procedure: Sham Dry Needling, Procedure: Local Anesthehetic InjectionPatients will recieve %1 Lidocaine injection to the upper trapezius muscles trigger points. They will also recieve a sham dry needling, where the needle will not penetrate to the skin but the tube of the needle will be contacted to the skin. |
| Dry Needling Group | Active comparator | Procedure: Dry NeedlingThis group will get 3 sessions of dry needling to the trigger points on upper trapezius muscle. |
| Local Aensthetic injection + Dry Needling Group | Experimental | Procedure: Dry Needling, Procedure: Local Anesthehetic InjectionThis group will get trigger point local anesthetic injection and 3 sessions of dry needling terapy to the trigger points on upper trapezius muscle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between 18 and 65 years of age
Key exclusion criteria (13 listed)
- Having a diagnosis of cervical disc herniation, cervical radiculopathy, or myelopathy
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 NeedlingDry needling is a procedure where an acupuncture needle is penetrated to the active myofascial trigger point in a muscle, until a twitch response is gained. Patients will be lied supine and an examiner with 10 years of experience will palpate the upper trapezius muscle. Identified active myofascial trigger points will be penetrated with acupuncture needles until the twitch response is obtained. | Procedure or surgery | Dry Needling Group, Local Aensthetic injection + Dry Needling Group |
| Sham Dry NeedlingSham dry needling is a procedure where the needle does not penetrate to the skin or the muscle, but the tube of the needle will be contacted to the skin. | Procedure or surgery | Local Anesthetic Injection + Sham Dry Needling Group |
| Local Anesthehetic InjectionLocal anesthetic injection is a procedure where the %1 lidocaine ( 4 cc) is injected to the myofascial trigger points. Patient will be lying supine and the examiner with 10 years of experience will palpate the trapezius muscles upper part. Identified trigger points will be penetrated by a needle and will be injected lidocaine. | Procedure or surgery | Local Aensthetic injection + Dry Needling Group, Local Anesthetic Injection + Sham Dry Needling Group |
Primary outcome
Numeric Pain Rating Scale (NRS)
Time frame: It is the change from the baseline (pre-treatment) NRS (Numeric Pain Rating Scale) score to the NRS score at the 3rd month.
Numeric Pain Rating Scale (NRS): Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (the most severe pain) based on their own perception; the measurement will be conducted verbally by a qualified researcher in a calm environment
3 secondary outcomes
Neck Pain and Disability Scale (NPADS
Time frame: 3 months
QuickDASH
Time frame: 3 months
Pressure Pain Threshold (PPT)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dry Needling and Local Anesthehetic Injection in people with Myofascial Pain of Upper Trapezius Muscle, run by Emre Ata, Assoc Prof 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 13 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: opening soon, as of the sponsor's last update on 6 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact muhammed G GÖRGEL, Resident Doctor (+905462388649, mgorgelitf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NRS) (time frame: It is the change from the baseline (pre-treatment) NRS (Numeric Pain Rating Scale) score to the NRS score at the 3rd month.). 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 6 Mar 2026.