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NCT Number: NCT06664359

Safe Zone in Trigger Point Injection

The goal of this observational study is to define the safe distance that will reduce the risk of pneumothorax through ultrasonographic imaging measurements in both sitting and prone positions to ensure patient safety during these procedures. The main question[s] it aims to answer [is/are]:

The mean distance between the skin and pleura in sitting position during the inhalation and exhalation The mean distance between the skin and pleura in prone position during the inhalation and exhalation

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Department of Anesthesiology and Reanimation

Ankara, 06230, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büsra Sahin Kıdam, MD

PRINCIPAL_INVESTIGATOR

Hanzade Ünal, MD

CONTACT

[email protected]

+905057179039

Süheyla Karadağ Erkoç, MD

CONTACT

[email protected]

About this study

Myofascial pain syndrome is characterized by pain and tenderness at specific points known as trigger points. Tension and spasm occur in the muscles, making it one of the most common causes of musculoskeletal pain. Various treatment options, such as TENS, dry needling, and trigger point injections, are available for the management of myofascial pain syndrome. Trigger point injection is one of the evidence based treatment methods that can provide both temporary and long-term relief.

Trigger point injections can be performed under ultrasound guidance or by blind technique. Although trigger point injection is generally be considered a safe procedure when performed by a skilled practitioner, complications may occur. These complications include pain during and after the procedure, nerve injury, bleeding, infection, and serious complications such as pneumothorax. Pneumothorax may occur when trigger point injections are administered into the chest wall muscles, particularly the trapezius, rhomboid major, or rhomboid minor muscles. Among these muscles, the rhomboid major is very thin, and the thickness of the skin, subcutaneous fat layer, and other soft tissues surrounding it varies between individuals. Since nerves, vascular structures, and the pleura are present in the deeper parts of these muscles, determining the appropriate injection depth is crucial.

In clinical practice, trigger point injections are administered by clinicians in both prone and sitting positions. To the best of our knowledge there is no studies thatinvestigates the determination of a safe distance through measurements in both the sitting and prone positions. In this study we aim to calculate the safe distance using ultrasound that will reduce the risk of pneumothorax through ultrasonographic imaging measurements in both sitting and prone positions during inhalation and exhalation to ensure patient safety during these procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with Myofascial Pain Syndrome
  • patients scheduled for trigger point injections due to Myofascial Pain Syndrome.

Exclusion criteria

  • under 18 years of age,
  • additional diseases other than Myofascial Pain Syndrome,
  • the presence of active infection in the interscapular area where ultrasound imaging and measurements will be performed,
  • lesions that disrupt skin integrity or affect subcutaneous and muscle structures such as anomalies or masses that could impair imaging quality
  • individuals with known lung diseases
  • not consent to participate in the study."

Treatment and study plan

Ultrasound guided injection with local anaestethic

Other

Volunteers will first be asked to sit on a chair with their back facing the examiner, placing their arms in a relaxed position with their head supported on a surface in front of them. The ultrasound operator will be positioned behind the volunteer. Initially, in the sitting position, volunteers will be asked to maintain normal breathing. Once an optimal ultrasound image is obtained, the image will be frozen, and measurements will be taken from the same image in sequence. The measurements to be performed are as follows: skin-fat tissue distance, skin-trapezius muscle distance, skin-rhomboid muscle distance, skin-rib distance, skin-pleura distance, and rhomboid muscle-pleura distance. These measurements, in millimeters, will be recorded in the data collection form. The same measurements will also be taken during deep inhalation and deep exhalation in the sitting position."

Primary outcomes

  1. skin-pleura distance in sitting position

    Time frame: 1 day

    Evaluate the skin-pleura distance in sitting position during inhalation and exhalation

  2. skin-pleura distance in prone position

    Time frame: 1 day

    skin-pleura distance in prone position during inhalation and exhalation

Secondary outcomes

  1. the correlation of skin-pleura distance and body mass index

    Time frame: 1 day

    the correlation of skin-pleura distance in sitting and prone position and body mass index

  2. the correlation of skin-pleura distance and dominant hand

    Time frame: 1 day

    the correlation of skin-pleura distance in sitting and prone position and dominant hand

  3. the correlation of skin-pleura distance and the chest wall diameter

    Time frame: 1 day

    the correlation of skin-pleura distance in sitting and prone position and the chest wall diameter

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra Şahin Kıdam, MD

CONTACT

[email protected]

+905448387763 ext. +905448387763

Süheyla Karadağ Erkoç, MD

CONTACT

[email protected]

+905063994839 ext. +905063994839

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Avoid Pneumothorax: Identification of the Interscapular Area Trigger Point Injection Safe Zone in Different Positions (Sitting/Prone)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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