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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

Comparison of the Effectivenes of Combined Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome in Upper Trapezius Muscle

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07456735
Enrollment
90
Registered
2026-03-06
Start date
2026-03-01
Completion date
2026-06-10
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain of Upper Trapezius Muscle

Keywords

myofascial pain syndrome,trigger points,dry needling

Brief 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 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.

Interventions

PROCEDUREDry Needling

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.

PROCEDURESham Dry Needling

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.

PROCEDURELocal Anesthehetic Injection

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.

Sponsors

Emre Ata, Assoc Prof
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

3

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating Scale (NRS)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

Secondary

MeasureTime frameDescription
Neck Pain and Disability Scale (NPADS3 monthsNeck 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.
QuickDASH3 monthsQuickDASH: 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.
Pressure Pain Threshold (PPT)3 monthsPressure 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTmuhammed G GÖRGEL, Resident Doctor
mgorgelitf@gmail.com+905462388649

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026