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Bilateral Erector Spinae Plane Block for Myofascial Pain Syndrome

Primary Purpose

Myofascial Pain Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral thoracal erector spinae plane block
Trapezius muscle trigger point injection
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Myofascial Pain Syndrome focused on measuring Erector spinae plane block, Myofascial pain syndrome, Trigger point, Algometer, Visual Analog Scale, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Istanbul Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bilateral Erector Spinae Plane Block

Trigger Point Injection

Arm Description

Bilateral Erector Spinae Plane Block

Trapezius muscle Trigger Point Injection

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 5, 2022
Last Updated
October 3, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05565053
Brief Title
Bilateral Erector Spinae Plane Block for Myofascial Pain Syndrome
Official Title
Bilateral Erector Spinae Plane Block for Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
October 27, 2022 (Anticipated)
Study Completion Date
December 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Erector spinae plane block, Myofascial pain syndrome, Trigger point, Algometer, Visual Analog Scale, Pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing the efficacy of erector spina plan block and trigger point injection in patients with myofascial pain syndrome
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral Erector Spinae Plane Block
Arm Type
Active Comparator
Arm Description
Bilateral Erector Spinae Plane Block
Arm Title
Trigger Point Injection
Arm Type
Active Comparator
Arm Description
Trapezius muscle Trigger Point Injection
Intervention Type
Procedure
Intervention Name(s)
Bilateral thoracal erector spinae plane block
Intervention Description
Bilateral upper thoracal erector spinae plane block with ultrasound
Intervention Type
Procedure
Intervention Name(s)
Trapezius muscle trigger point injection
Intervention Description
Trapezius muscle trigger point injection
Primary Outcome Measure Information:
Title
Comparison of the effectiveness of the two interventions (trigger point injection versus Erector spinae plane block) assessed by Visual analog scale (VAS):
Description
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.
Time Frame
Baseline
Title
Comparison of the effectiveness of the two interventions (trigger point injection versus Erector spinae plane block) assessed by Visual analog scale (VAS):
Description
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.
Time Frame
1. month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil Çetingök
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34104
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Bilateral Erector Spinae Plane Block for Myofascial Pain Syndrome

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