Effectiveness of Serratus Posterior Superior Intercostal Plane Block Applied With Ultrasonography in Myofascial Pain Syndrome

August 14, 2024 updated by: Halil Ibrahim Altun

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.

Study Overview

Status

Status

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Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

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Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • Recruiting
        • Kanuni Sultan Suleyman Training and Research Hospital
        • Contact:

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
onset of pain and application time of intervention Visual Analog Scale (VAS)
Time Frame: four months
four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halil Ibrahim Altun

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

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August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MyofascialPainSyndrome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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