Clinical trial NCT06664359: Safe Zone in Trigger Point Injection
Official title: Avoid Pneumothorax: Identification of the Interscapular Area Trigger Point Injection Safe Zone in Different Positions (Sitting/Prone)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trigger Point Pain, Myofascial
Keywords: Trigger Point Pain
Myofascial pain
ultrasound
pneumothorax
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo trigger point injections due to myofascial pain

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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."

Primary outcomes:
measure: skin-pleura distance in sitting position
timeFrame: 1 day
measure: skin-pleura distance in prone position
timeFrame: 1 day
Secondary outcomes:
measure: the correlation of skin-pleura distance and body mass index
timeFrame: 1 day
measure: the correlation of skin-pleura distance and dominant hand
timeFrame: 1 day
measure: the correlation of skin-pleura distance and the chest wall diameter
timeFrame: 1 day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Department of Anesthesiology and Reanimation
Study officials:
affiliation: Department of Anesthesiology and Reanimation, Ankara University, Ankara, Turkey
name: Suheyla Karadağ-Erkoç, MD
role: STUDY_DIRECTOR
References:
citation: Mitchell UH, Johnson AW, Larson RE, Seamons CT. Positional changes in distance to the pleura and in muscle thickness for dry needling. Physiotherapy. 2019 Sep;105(3):362-369. doi: 10.1016/j.physio.2018.08.002. Epub 2018 Aug 18.