Bilateral Erector Spinae Plane Block for Myofascial Pain Syndrome

Myofascial Pain Syndrome Clinical Trial

Official title:

Bilateral Erector Spinae Plane Block for Myofascial Pain Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05565053
• Other study ID #: 2019/725
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 25, 2021
• Est. completion date: December 29, 2022

Study information

• Verified date: September 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The investigators aimed to evaluate the effectiveness of bilateral erector spina plane block application in myofascial pain syndrome by comparing trigger point injection. Group 1 only one time erector spinae plane block and group 2 once a week total three times trigger point injection. Before the application, one week after application and one month after first application the investigators aimed to compare pressure pain threshold with algometer, visual analog scale score, short form-36 score, neck disability index score, beck depression scale score for the two groups. Each group has 30 participants, total 60 participants included this study. The investigators planned to show that bilateral erector spinae plane block can be used as an effective and safe method in the treatment of myofascial pain syndrome, since it is easier to apply than other invasive procedures used in the treatment and has a very low complication profile.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 29, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Cervical disc herniation
• Neck/shoulder, thoracal trauma or operation history
• Malignancy
• Kyphoscoliosis
• Inflammatory diseases (Rheumatoid arthritis, ankylosing spondylitis...)
• Congenital vertebral anomalies
• Neck pain with neurological deficit
• 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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• Bilateral thoracal erector spinae plane block
Bilateral upper thoracal erector spinae plane block with ultrasound
• Trapezius muscle trigger point injection
Trapezius muscle trigger point injection

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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