Trigger Point Pain, MyofascialNCT06664359
Safe Zone in Trigger Point Injection
An observational study of Trigger Point Pain, Myofascial, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trigger Point Pain, Myofascial
- What is being tested?
- Ultrasound guided injection with local anaestethic
- Type of treatment
- Injection or infusion
- How many people
- 211 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 30 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo trigger point injections due to myofascial pain
Who may be able to join
- patients diagnosed with Myofascial Pain Syndrome
- patients scheduled for trigger point injections due to Myofascial Pain Syndrome.
Who cannot join
- 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."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Department of Anesthesiology and Reanimation
Ankara, 06230
Süheyla Karadağ Erkoç, MD, hanzadeunal@windowslive.com
Hanzade Ünal, MD, +905057179039, hanzadeunal@windowslive.com
About this study
Official title: Avoid Pneumothorax: Identification of the Interscapular Area Trigger Point Injection Safe Zone in Different Positions (Sitting/Prone)
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
Read the 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.
- Conditions
- Trigger Point Pain, Myofascial
- Being tested
- Ultrasound guided injection with local anaestethic
- Keywords
- Trigger Point Pain, Myofascial pain, ultrasound, pneumothorax
- Medical subject headings
- Myofascial Pain Syndromes, Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided injection with local anaestethicOther
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."
Ultrasound guided injection with local anaestethicOther
Volunteers will first be asked to lay prone position.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."
| Study group | Role | What they receive |
|---|---|---|
| myofascial pain | myofascial pain syndrome Receives: Other: Ultrasound guided injection with local anaestethic |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin-pleura distance in sitting position
Evaluate the skin-pleura distance in sitting position during inhalation and exhalation
Measured: 1 day
skin-pleura distance in prone position
skin-pleura distance in prone position during inhalation and exhalation
Measured: 1 day
Secondary outcomes (3)
the correlation of skin-pleura distance and body mass index
the correlation of skin-pleura distance in sitting and prone position and body mass index
Measured: 1 day
the correlation of skin-pleura distance and dominant hand
the correlation of skin-pleura distance in sitting and prone position and dominant hand
Measured: 1 day
the correlation of skin-pleura distance and the chest wall diameter
the correlation of skin-pleura distance in sitting and prone position and the chest wall diameter
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 211 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süheyla Karadağ Erkoç, Ankara University
- Investigators
- Suheyla Karadağ-Erkoç, MD, Study director, Department of Anesthesiology and Reanimation, Ankara University, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664359
- Sponsor's protocol ID
- 2024/376
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30343872
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoid Pneumothorax: Identification of the Interscapular Area Trigger Point Injection Safe Zone in Different Positions (Sitting/Prone)
- ClinicalTrials.gov ID
- NCT06664359
- Acronym / sponsor ID
- 2024/376
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- Trigger Point Pain, Myofascial pain, ultrasound, pneumothorax
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myofascial pain | – | Other: Ultrasound guided injection with local anaestethicmyofascial pain syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo trigger point injections due to myofascial pain
Key inclusion criteria (2 listed)
- patients diagnosed with Myofascial Pain Syndrome
- patients scheduled for trigger point injections due to Myofascial Pain Syndrome.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided injection with local anaestethicVolunteers 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." | Other | myofascial pain |
| Ultrasound guided injection with local anaestethicVolunteers will first be asked to lay prone position.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." | Other | myofascial pain |
Primary outcome
skin-pleura distance in sitting position
Time frame: 1 day
Evaluate the skin-pleura distance in sitting position during inhalation and exhalation
skin-pleura distance in prone position
Time frame: 1 day
skin-pleura distance in prone position during inhalation and exhalation
3 secondary outcomes
the correlation of skin-pleura distance and body mass index
Time frame: 1 day
the correlation of skin-pleura distance and dominant hand
Time frame: 1 day
the correlation of skin-pleura distance and the chest wall diameter
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publication: PubMed 30343872Mitchell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suheyla Karadağ-Erkoç, MD study director
Department of Anesthesiology and Reanimation, Ankara University, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Point Pain, Myofascial, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Süheyla Karadağ Erkoç, MD (+905063994839 ext. +905063994839, suheylakaradag@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin-pleura distance in sitting position (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.