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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEmre Ata, Assoc Prof

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dry Needling

    Procedure/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 Needling

    Procedure/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 Injection

    Procedure/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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Local Anesthetic Injection + Sham Dry Needling GroupSham comparator 2 interventions
Group B: Dry Needling GroupActive comparator 1 intervention
Group C: Local Aensthetic injection + Dry Needling GroupExperimental treatment 2 interventions

Trial outcomes

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

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.

Secondary outcomes

1

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.

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

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Emre Ata, Assoc Prof

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Sponsor institution

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