Safe Zone in Trigger Point Injection

NCT06664359 | Recruiting

• 1 other identifier: 2024/376
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

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

Conditions

Trigger Point Pain, Myofascial

Keywords

Trigger Point Pain; Myofascial pain; ultrasound; pneumothorax

Outcome Measures

Primary Outcomes (2)

• skin-pleura distance in sitting position

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

  1 day

• skin-pleura distance in prone position

  skin-pleura distance in prone position during inhalation and exhalation

  1 day

Secondary Outcomes (3)

• the correlation of skin-pleura distance and body mass index

  1 day

• the correlation of skin-pleura distance and dominant hand

  1 day

• the correlation of skin-pleura distance and the chest wall diameter

  1 day

Study Arms (1)

myofascial pain

myofascial pain syndrome

Other: Ultrasound guided injection with local anaestethic

Interventions

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."

myofascial pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo trigger point injections due to myofascial pain

You may qualify if:

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

You may not qualify if:

• 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."

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Department of Anesthesiology and Reanimation

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 30343872 RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes; Pneumothorax

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Suheyla Karadağ-Erkoç, MD

  Department of Anesthesiology and Reanimation, Ankara University, Ankara, Turkey

  STUDY DIRECTOR

Central Study Contacts

Süheyla Karadağ Erkoç, MD

CONTACT

+905063994839; suheylakaradag@hotmail.com

Büşra Şahin Kıdam, MD

CONTACT

+905448387763; kidambusra@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)