Dry Needling Combined With a Therapeutic Exercise Program in Myofascial Pain Syndrome: Sonographic Evaluation of Cervical Muscles

NCT06809790 | Completed

• 1 other identifier: 18/09/2024;2024-KAEK-30;114
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Patients between the ages of 20-65 years who present to the Physical Medicine and Rehabilitation outpatient clinics of our hospital with complaints of back and neck pain and are diagnosed with myofascial pain syndrome will be referred to the physicians responsible for the study to be included in the study. Exclusion criteria will be reviewed, and patients with chronic pain for more than 3 months and an active trigger point in the unilateral upper trapezius muscle will be included in the study. Patients will be randomly divided into two groups; the first group will receive only exercise therapy (including cervical range of motion and trapezius stretching), and the second group will receive exercise and dry needling therapy (1 time per week, 3 sessions in total). Demographic data (age, gender, body mass index, occupation) of all patients included in the study will be recorded. The relationship between pain and loss of function according to the Visual Analog Scale (VAS), Short Form 36 (SF-36), and Neck Disability Index (NDI) scales will be recorded. Bilateral upper trapezius, sternocleidomastoideus, and total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus) and longus colli muscle thickness measurements will be made with the ultrasonography device in our clinic. The first group will receive only exercise therapy after the measurements. Patients in the second group will receive a total of 3 sessions of dry needling treatment to the trapezius muscle for active trigger points at 0, 1, and 2 weeks in addition to exercise therapy. After the initial examination, control VAS, SF-36, NDI, and control ultrasonographic measurements will be performed in all patients at the 3rd week and 6th week. Using data analysis methods, the effect of dry needling treatment for active trigger points in the trapezius muscle on pain and functionality as well as the thickness of the cervical muscles will be investigated.

Conditions

Myofascial Pain Syndrome - Neck; Myofascial Pain of Upper Trapezius Muscle

Keywords

myofascial pain syndrome; trigger point; dry needling; upper trapezius muscle; Therapeutic Exercise

Outcome Measures

Primary Outcomes (1)

• Ultrasonographic evaluation for muscle thickness assessment

  Bilateral upper trapezius, sternocleidomastoid, total cervical extensor muscle thickness (upper trapezius, splenius capitis, semispinalis capitis, semispinalis cervicis, and multifidus), and longus colli muscle thickness measurements will be made with the ultrasonography device.

  It will be evaluated in the baseline, third, and sixth weeks.

Secondary Outcomes (3)

• Pain will be assessed with Visual Analog Scale.

  It will be evaluated in the baseline, third, and sixth weeks.

• Functional status will be assessed with the Neck Disability Index.

  It will be evaluated in the baseline, third, and sixth weeks.

• General health status will be assessed with Short Form 36.

  It will be evaluated in the baseline, third, and sixth weeks.

Study Arms (2)

Group 1: Therapeutic Exercise

ACTIVE COMPARATOR

Behavioral: Therapeutic Exercise Program

Group 2: Therapeutic Exercise and Dry Needling

ACTIVE COMPARATOR

Behavioral: Therapeutic Exercise Program; Procedure: Dry Needling

Interventions

Therapeutic Exercise Program BEHAVIORAL

Participants in this group will receive a therapeutic exercise program (including cervical range of motion and trapezius stretching) during the study period.

Group 1: Therapeutic Exercise; Group 2: Therapeutic Exercise and Dry Needling

Dry Needling PROCEDURE

Participants in this group will receive dry needling treatment for active trigger points in addition to the therapeutic exercise program. Dry needling treatment will be applied in a total of 3 sessions at 0, 1, and 2. weeks, one week apart.

Group 2: Therapeutic Exercise and Dry Needling

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20-65 years with neck pain for more than 12 weeks
• Active trigger point in the unilateral upper trapezius muscle on physical examination
• Who agreed not to receive anti-inflammatory and myorelaxant treatment during the study period

You may not qualify if:

• Patients diagnosed with rheumatologic diseases
• Patients with radiculopathy
• Patients with a history of previous surgery in the shoulder, back, and neck region
• Patients with polyneuropathy
• Patients with severe cervical spondylosis
• Patients with cerebrovascular events
• Patients with malignancies
• Those with cognitive impairment
• Those with bleeding disorders
• Patients diagnosed with fibromyalgia
• Patients with thyroidectomy
• Anti-inflammatory-analgesic or myorelaxant treatment within the last 1 month
• Patients with a history of injection into the upper trapezius muscle or cervical region within the last 3 months

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Fatih, 34093, 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

Study Officials

• Muhammed Oğuz

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Participants will be randomly divided into two groups; the first group will receive only exercise therapy, and the second group will receive exercise therapy as well as dry needling treatment.

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 5, 2025
• Study Start: February 9, 2025
• Primary Completion: July 25, 2025
• Study Completion: August 15, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

TU (1)