NCT05565053

Brief Summary

The investigators aimed to evaluate the effectiveness of bilateral erector spina plane block application in myofascial pain syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 25, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

3.4 years

First QC Date

August 5, 2022

Last Update Submit

May 12, 2026

Conditions

Keywords

Erector spinae plane blockMyofascial pain syndromeTrigger pointAlgometerVisual Analog ScalePain

Outcome Measures

Primary Outcomes (2)

  • Comparison of the effectiveness of the two interventions (trigger point injection versus Erector spinae plane block) assessed by Visual analog scale (VAS):

    The classic interventional treatment of myofascial back pain is trigger point injection. In addition, erector spina plan block has been applied in recent years as an interventional procedure that provides analgesia in the same region and is thought to have a long duration of action. Visual analog scale (VAS): Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    Baseline

  • Comparison of the effectiveness of the two interventions (trigger point injection versus Erector spinae plane block) assessed by Visual analog scale (VAS):

    The classic interventional treatment of myofascial back pain is trigger point injection. In addition, erector spina plan block has been applied in recent years as an interventional procedure that provides analgesia in the same region and is thought to have a long duration of action. Visual analog scale (VAS): Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    1. month

Study Arms (2)

Bilateral Erector Spinae Plane Block

ACTIVE COMPARATOR

Bilateral Erector Spinae Plane Block

Procedure: Bilateral thoracal erector spinae plane block

Trigger Point Injection

ACTIVE COMPARATOR

Trapezius muscle Trigger Point Injection

Procedure: Trapezius muscle trigger point injection

Interventions

Bilateral upper thoracal erector spinae plane block with ultrasound

Bilateral Erector Spinae Plane Block

Trapezius muscle trigger point injection

Trigger Point Injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Get a myofascial pain syndrome diagnosis
  • No invasive procedure for myofascial pain syndrome in the last 1 month
  • Signing the informed consent form

You may not qualify if:

  • Cervical disc herniation
  • Neck/shoulder, thoracal trauma or operation history
  • Malignancy
  • Kyphoscoliosis
  • Inflammatory diseases (Rheumatoid arthritis, ankylosing spondylitis...)
  • Congenital vertebral anomalies
  • Pregnancy
  • Mental, psychogenic disorder
  • Hematological diseases that cause bleeding and coagulation disorders
  • Use of antiplatelet, anticoagulant and drugs that cause bleeding tendency
  • Severe systemic infection such as sepsis and local infection at the intervention site
  • Having an allergy to any of the drugs to be used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34104, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Halil Çetingök

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Comparing the efficacy of erector spina plan block and trigger point injection in patients with myofascial pain syndrome
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof

Study Record Dates

First Submitted

August 5, 2022

First Posted

October 4, 2022

Study Start

July 25, 2021

Primary Completion

January 1, 2025

Study Completion

March 1, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations