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 | Not Yet Recruiting Phase 4

• 1 other identifier: SultanAbdülhamidftr2
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain of Upper Trapezius Muscle

Keywords

myofascial pain syndrome,trigger points,dry needling

Outcome Measures

Primary Outcomes (1)

• 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

  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

  3 months

• QuickDASH

  3 months

• Pressure Pain Threshold (PPT)

  3 months

Study Arms (3)

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.

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.

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

Procedure: Dry Needling; Procedure: Local Anesthehetic Injection

Interventions

Dry Needling PROCEDURE

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.

Dry Needling Group; Local Aensthetic injection + Dry Needling Group

Sham Dry Needling PROCEDURE

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 Anesthetic Injection + Sham Dry Needling Group

Local Anesthehetic Injection PROCEDURE

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.

Local Aensthetic injection + Dry Needling Group; Local Anesthetic Injection + Sham Dry Needling Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Emre Ata, Assoc Prof: lead

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, ÜSKÜDAR, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

muhammed G GÖRGEL, Resident Doctor

CONTACT

+905462388649; mgorgelitf@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, MD

Model Details: 3

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion: April 20, 2026
• Study Completion: June 10, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

TU (1)