Clinical trial NCT06809790: Dry Needling Combined with a Therapeutic Exercise Program in Myofascial Pain Syndrome: Sonographic Evaluation of Cervical Muscles
Official title: The Effect of Dry Needling of the Upper Trapezius Muscle Added to Therapeutic Exercise Therapy on the Thickness of the Cervical Muscles in Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myofascial Pain Syndrome - Neck
Myofascial Pain of Upper Trapezius Muscle
Keywords: myofascial pain syndrome
trigger point
dry needling
upper trapezius muscle
Therapeutic Exercise
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-05
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ultrasonographic evaluation for muscle thickness assessment
timeFrame: It will be evaluated in the baseline, third, and sixth weeks.
Secondary outcomes:
measure: Pain will be assessed with Visual Analog Scale.
timeFrame: It will be evaluated in the baseline, third, and sixth weeks.
measure: Functional status will be assessed with the Neck Disability Index.
timeFrame: It will be evaluated in the baseline, third, and sixth weeks.
measure: General health status will be assessed with Short Form 36.
timeFrame: It will be evaluated in the baseline, third, and sixth weeks.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
state: Fatih
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Muhammed Oğuz
role: PRINCIPAL_INVESTIGATOR
References: