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
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
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
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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