Ireland
--:--IST
Recruiting Not applicable

The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome

NCT06338488 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-04-25
Last updated
2026-08-24

Condition(s) studied

Shoulder Pain

Investigational drug(s) / intervention(s)

Real dry needlingSham dry needling

Real dry needling: dry needling into the muscle under ultrasound guidance.

Sham dry needling: dry needling into the subcutaneous fatty tissue under ultrasound guidance.

Study summary

Myofascial pain can be diagnosed by the presence of one or more myofascial trigger points (MTrPs), defined as hyperirritable spots in taut bands of skeletal muscle fibers palpable by hand. The treatment of myofascial pain primarily relies on the inactivation of MTrPs, often through manual pressure techniques or dry needling. In manual pressure techniques, the physiotherapist applies increasing pressure directly to the MTrP. In dry needling, acupuncture-like filiform needles are applied to the same point. There are two types of dry needling: superficial dry needling, which penetrates only the skin and superficial muscle, and deep dry needling, which involves inserting a needle directly into the MTrP. The sole or adjunct effectiveness of dry needling treatment targeting the trapezius and infraspinatus muscles has been investigated, particularly in patients with shoulder myofascial pain syndrome. In the study we are planning, a double-blinded efficacy trial will be conducted in patients with shoulder myofascial pain syndrome, where real and sham dry needling applications will be performed under ultrasound guidance, with both the patient and the evaluator blinded. This study design has the potential to make a significant contribution to the literature in this field.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Clinically diagnosed with Shoulder Myofascial Pain Syndrome associated with Infraspinatus trigger point. * Having a shoulder pain Visual Analog Scale (VAS) score of 6 or higher. * Ability to read and write Exclusion Criteria: * History of shoulder surgery and frozen shoulder syndrome. * Lesions, atrophy, or scars in the skin around the shoulder. * Having undergone physiotherapy targeting the shoulder in the last 6 months. * Undergoing an interventional procedure for shoulder pain in the last 3 months. * Having used steroids in the last 1 month. * Special conditions such as epilepsy, pregnancy, injection phobia, etc. * Inability to comply with the restriction on the use of steroid and non-steroidal anti-inflammatory drugs during the treatment period.

Primary outcome measure(s)

  • Visual Analog Scale — Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: One week after the last intervention, Time frame 4: One month after the last intervention
    "Visual Analog Scale (VAS)" is a measurement instrument often used in healthcare to assess the intensity or characteristics of subjective experiences such as pain. It typically consists of a straight line, usually 10 centimeters in length, with endpoints representing extremes (e.g., "no pain" to "worst imaginable pain"). Patients mark on the line to indicate their subjective experience, and the distance from one endpoint provides a numerical score representing the intensity of the sensation being measured. The VAS is commonly employed in pain assessment but can also be adapted for various other subjective evaluations.
  • Patient-Specific Functional Scale — Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: One week after the last intervention, Time frame 4: One month after the last intervention
    "Patient-Specific Functional Scale" (PSFS). The PSFS is a self-report outcome measure commonly used in healthcare, particularly in physical therapy and rehabilitation settings. It is designed to assess the patient's perceived difficulty in performing specific activities that are relevant to their daily life and function. Identification of Activities: The patient is asked to identify and list three to five activities that they find challenging or have difficulty performing due to their condition or symptoms. Rating Scale: For each identified activity, the patient is asked to rate their current level of difficulty on a numerical scale, often ranging from 0 to 10. A score of 0 indicates no difficulty, while 10 indicates the maximum difficulty. Follow-up Assessments: The same activities and rating scale are used in follow-up assessments to track changes over time or in response to interventions.
  • Pressure Pain Threshold Measurement — Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: One week after the last intervention, Time frame 4: One month after the last intervention
    "Pressure Pain Threshold Measurement" refers to the assessment of the amount of pressure applied to a specific point on the body before the individual perceives it as painful. This measurement is commonly used in clinical settings to evaluate pain sensitivity and threshold. The process involves gradually applying pressure to a specific area until the individual signals that they begin to feel pain. It is a quantitative way to assess pain perception and is often utilized in research, physical therapy, and other healthcare disciplines to understand pain levels and responses.

Trial sites (1)

FacilityCityRegionStatus
Kütahya Health Sciences University Kütahya Türkiye 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 NCT06338488 on ClinicalTrials.gov ↗ ← All trials in Turkey