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

NCT07456735 · tracked via the Priya Life Science Turkey tracker

Sponsor

Emre Ata, Assoc Prof

Phase

Phase 4

Started

2026-03-01

Last updated

2026-03-06

Condition(s) studied

Myofascial Pain of Upper Trapezius Muscle

Investigational drug(s) / intervention(s)

Dry NeedlingSham Dry NeedlingLocal Anesthehetic Injection

Dry 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.

Sham 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.

Local 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Sultan Abdulhamid Han Training and Research Hospital	Istanbul	ÜSKÜDAR

Other trials for the same condition

Comparison of the Effectiveness of Exercise, Dry Needling and Interfascial Block Treatments in the Treatment of Myofascial Pain Syndrome Recruiting

Percutaneous Electrolysis of the Upper Trapezius in Chronic Neck Pain Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07456735 on ClinicalTrials.gov ↗ ← All trials in Turkey