NCT06557993

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

August 12, 2024

Last Update Submit

August 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • onset of pain and application time of intervention Visual Analog Scale (VAS)

    four months

Interventions

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
pain specialist

Study Record Dates

First Submitted

August 12, 2024

First Posted

August 16, 2024

Study Start

June 1, 2023

Primary Completion

August 20, 2024

Study Completion

October 1, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations