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

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Myofascial Pain of Upper Trapezius Muscle

In brief

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.

Key facts

Study ID

NCT07456735

Run by

Emre Ata, Assoc Prof

People needed

90

Starts

2026-03-01

Expected to finish

2026-06-10

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Sultan Abdulhamid Han Training and Research Hospital — Istanbul, ÜSKÜDAR, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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