Pain, NeckNCT06557993
Effectiveness of Serratus Posterior Superior Intercostal Plane Block Applied With Ultrasonography in Myofascial Pain Syndrome
An observational study of Pain, Neck, run by Halil Ibrahim Altun at 1 site in Turkey (Türkiye).
Trial summary
Trigger point treatment in myofascial pain syndrome should be planned according to its etiology to prevent relapses. Although there are various modalities, in cases where medical and noninvasive methods are ineffective, diluted local anesthetic injections or diluted local anesthetic injections with steroids, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Neck
- What is being tested?
- Serratus Posterior Superior Intercostal Plane Block
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: * Cervical disc herniation, * history of trauma/operation to the neck, * shoulder or back area, malignancy, presence of kyphoscoliosis, * inflammatory diseases (rheumatoid arthritis, ankylosing spondylitis, etc.), * congenital anomalies of the spine, neck pain accompanied by neurological deficit, * pregnancy, mental or psychotic disorder, bleeding and Hematological diseases that cause coagulation disorders, use of antiplatelet, anticoagulant and drugs that cause bleeding tendencies, serious systemic and local infection in the intervention area such as sepsis, and allergy to any of the drugs to be used.
Who may be able to join
- Being between the ages of 18-65 and having been diagnosed with MAS based on the MAS diagnostic criteria,
- No invasive procedure has been performed for this disease in the last 3 months
- Signing the informed consent form
- Patients with complete data to be scanned in their files
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 34000
halil ibrahim altun, specialist, +9005072774773, halilibrahim_altun@yahoo.com
About this study
Trigger point treatment in myofascial pain syndrome should be planned according to its etiology to prevent relapses. Although there are various modalities, in cases where medical and noninvasive methods are ineffective, diluted local anesthetic injections or diluted local anesthetic injections with steroids, and sometimes dry needling or botulinum toxin, are preferred. In recent years, imaging methods such as ultrasonography have been frequently used for trigger point injections. These injections may be repeated for several sessions depending on the patient's response. Pain, local anesthetic toxicity, bleeding, allergic reactions, pneumothorax, intramuscular hematoma, cerebrovascular events, spinal injury, vasovagal syncope and infections have been reported during injections. Therefore, during trigger point injections, vascular access should be established in the patient, the patient should be monitored, injections should be performed under sterile conditions, and an emergency kit should be kept ready in all cases .
The serratus posterior superior muscle is located deep to the rhomboid major and minor. Ligamentum nuchae starts from the processus spinosus of C7-T3 vertebrae and extends to the 2nd-5th. In the ribs, the angulus ends at the upper edge of the rib. Serratus posterior superior -intercostal plane block (SPSİPB) is a newly defined block, and C7-T7 spread has been shown in cadaver studies . In our study, investigators compared the newly defined SPSİPB, which is practical to be applied with USG in Myofascial Pain Syndrome (MAS), which is frequently seen especially in young people and desk workers, with trigger point injection, which has been used in the treatment of MAS for many years and whose effectiveness has been proven, and SPSİPB applied from a single point with USG guidance. investigators aimed to contribute to the literature regarding the effectiveness of in MAS. The newly defined rhomboid intercostal plane block and SPSIPB are routinely applied successfully in our algology clinic in patients with MAS and postzoster neuralgia in the thoracic region.
Read the detailed description
Myofascial Pain Syndrome is a condition characterized by sensory, motor and autonomic symptoms caused by trigger points (TN), which have a source of pain within the muscle and fascia. Trigger points are hyperirritable points located within taut bands. The aim of the treatment is to inactivate trigger points and relax tense muscle bands. The goal is to eliminate muscle tension and achieve normal muscle length, function and strength. Needling methods are still considered the most effective method in the initial treatment of MAS. Local anesthetic (LA) injection is a frequently used method with proven effectiveness .
Although the etiology of the ethical points accompanying MAS has not been elucidated; It is thought that posture disorders, vitamin-mineral deficiencies, metabolic diseases, genetic factors, stress and overuse disrupt the contraction-relaxation cycle in muscle sarcomeres. An acidic and hypoxic environment occurs in the muscle, inflammatory mediators are released, and this situation is more common in phasic muscles than in tonic muscles. Trigger points are divided into two: active and latent. In active trigger points, the patient's complaint is triggered by palpation and a jump sign is obtained, while in latent trigger points, pain occurs with palpation, but the patient's complaint is not triggered. During the examination, the trigger point is compressed and a local twitch response is obtained. Sometimes trigger points can also cause autonomic symptoms and referred pain .
The study was conducted at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital, between March 2023 and March 2024, on patients aged 18-65 who had MAS and therefore had serratus posterior superior intercostal plane block or trigger point injection applied to the neck-back region in a single session. It will be done by retrospectively scanning the files of the patients . Within the scope of the research, age, gender, Visual Analog Scale (VAS), Neck disability scores and Algometric measurements before and in the first and third months after the procedure will be scanned from patient files and those that can be accessed will be recorded.
- Conditions
- Pain, Neck
- Being tested
- Serratus Posterior Superior Intercostal Plane Block
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus Posterior Superior Intercostal Plane BlockOther
The serratus posterior superior muscle is located deep to the rhomboid major and minor. Ligamentum nuchae starts from the processus spinosus of C7-T3 vertebrae and extends to the 2nd-5th. In the ribs, the angulus ends at the upper edge of the rib. Serratus posterior superior -intercostal plane block (SPSİPB) is a newly defined block, and C7-T7 spread has been shown in cadaver studies
What is being measured
The primary outcome is the main question the study is designed to answer.
onset of pain and application time of intervention Visual Analog Scale (VAS)
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Jun 2023
- Primary completion20 Aug 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, NeckStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halil Ibrahim Altun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Halil Ibrahim Altun, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557993
- Sponsor's protocol ID
- MyofascialPainSyndrome
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Serratus Posterior Superior Intercostal Plane Block Applied With Ultrasonography in Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06557993
- Acronym / sponsor ID
- MyofascialPainSyndrome
- Conditions
- Pain, Neck
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Halil Ibrahim AltunUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 16 Aug 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.
Trigger point treatment in myofascial pain syndrome should be planned according to its etiology to prevent relapses. Although there are various modalities, in cases where medical and noninvasive methods are ineffective, diluted local anesthetic injections or diluted local anesthetic injections with steroids, and sometimes dry needling or botulinum toxin, are preferred. In recent years, imaging methods such as ultrasonography have been frequently used for trigger point injections. These injections may be repeated for several sessions depending on the patient's response. Pain, local anesthetic toxicity, bleeding, allergic reactions, pneumothorax, intramuscular hematoma, cerebrovascular events, spinal injury, vasovagal syncope and infections have been reported during injections. Therefore, during trigger point injections, vascular access should be established in the patient, the patient should be monitored, injections should be performed under sterile conditions, and an emergency kit should be kept ready in all cases .
The serratus posterior superior muscle is located deep to the rhomboid major and minor. Ligamentum nuchae starts from the processus spinosus of C7-T3 vertebrae and extends to the 2nd-5th. In the ribs, the angulus ends at the upper edge of the rib. Serratus posterior superior -intercostal plane block (SPSİPB) is a newly defined block, and C7-T7 spread has been shown in cadaver studies . In our study, investigators compared the newly defined SPSİPB, which is practical to be applied with USG in Myofascial Pain Syndrome (MAS), which is frequently seen especially in young people and desk workers, with trigger point injection, which has been used in the treatment of MAS for many years and whose effectiveness has been proven, and SPSİPB applied from a single point with USG guidance. investigators aimed to contribute to the literature regarding the effectiveness of in MAS. The newly defined rhomboid intercostal plane block and SPSIPB are routinely applied successfully in our algology clinic in patients with MAS and postzoster neuralgia in the thoracic region.
Detailed description
Myofascial Pain Syndrome is a condition characterized by sensory, motor and autonomic symptoms caused by trigger points (TN), which have a source of pain within the muscle and fascia. Trigger points are hyperirritable points located within taut bands. The aim of the treatment is to inactivate trigger points and relax tense muscle bands. The goal is to eliminate muscle tension and achieve normal muscle length, function and strength. Needling methods are still considered the most effective method in the initial treatment of MAS. Local anesthetic (LA) injection is a frequently used method with proven effectiveness .
Although the etiology of the ethical points accompanying MAS has not been elucidated; It is thought that posture disorders, vitamin-mineral deficiencies, metabolic diseases, genetic factors, stress and overuse disrupt the contraction-relaxation cycle in muscle sarcomeres. An acidic and hypoxic environment occurs in the muscle, inflammatory mediators are released, and this situation is more common in phasic muscles than in tonic muscles. Trigger points are divided into two: active and latent. In active trigger points, the patient's complaint is triggered by palpation and a jump sign is obtained, while in latent trigger points, pain occurs with palpation, but the patient's complaint is not triggered. During the examination, the trigger point is compressed and a local twitch response is obtained. Sometimes trigger points can also cause autonomic symptoms and referred pain .
The study was conducted at the Algology Department of Kanuni Sultan Süleyman Training and Research Hospital, between March 2023 and March 2024, on patients aged 18-65 who had MAS and therefore had serratus posterior superior intercostal plane block or trigger point injection applied to the neck-back region in a single session. It will be done by retrospectively scanning the files of the patients . Within the scope of the research, age, gender, Visual Analog Scale (VAS), Neck disability scores and Algometric measurements before and in the first and third months after the procedure will be scanned from patient files and those that can be accessed will be recorded.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Cervical disc herniation, * history of trauma/operation to the neck, * shoulder or back area, malignancy, presence of kyphoscoliosis, * inflammatory diseases (rheumatoid arthritis, ankylosing spondylitis, etc.), * congenital anomalies of the spine, neck pain accompanied by neurological deficit, * pregnancy, mental or psychotic disorder, bleeding and Hematological diseases that cause coagulation disorders, use of antiplatelet, anticoagulant and drugs that cause bleeding tendencies, serious systemic and local infection in the intervention area such as sepsis, and allergy to any of the drugs to be used.
Key inclusion criteria (4 listed)
- Being between the ages of 18-65 and having been diagnosed with MAS based on the MAS diagnostic criteria,
- No invasive procedure has been performed for this disease in the last 3 months
- Signing the informed consent form
- Patients with complete data to be scanned in their files
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Serratus Posterior Superior Intercostal Plane BlockThe serratus posterior superior muscle is located deep to the rhomboid major and minor. Ligamentum nuchae starts from the processus spinosus of C7-T3 vertebrae and extends to the 2nd-5th. In the ribs, the angulus ends at the upper edge of the rib. Serratus posterior superior -intercostal plane block (SPSİPB) is a newly defined block, and C7-T7 spread has been shown in cadaver studies | Other | – |
Primary outcome
onset of pain and application time of intervention Visual Analog Scale (VAS)
Time frame: four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- 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. This study is not recruiting at the moment.
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 Pain, Neck, run by Halil Ibrahim Altun 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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 16 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact halil ibrahim altun (+905072774773, halilibrahim_altun@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
onset of pain and application time of intervention Visual Analog Scale (VAS) (time frame: four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.