- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04405453
Contribution of Erector Spina Plane Block to Analgesia for Myofascial Pain Syndrome
August 18, 2020 updated by: Damla Yürük, Diskapi Teaching and Research Hospital
Contribution of Erector Spina Plane Block to Analgesia Combined With Ultrasound Guided Trapezius Muscle Injection for Myofascial Pain Syndrome
Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in one or more muscle groups.
It is characterized by myofascial trigger points that are felt as a band or a nodule harder than normal consistency located in the muscle.
Myofascial trigger points are developes as a result of muscle injury ; this can be acute trauma caused by sport injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional stress or poor posture.
Trigger point injection is the application of low dose local anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused by muscle spasm.However, it may reduce pain partially or have a short duration of action, so it may need to be repeated several times at regular intervals.Trigger point injection can reach trigger points in superficial muscles With the erector spina plane block technique, more effective and long-term pain treatment can be achieved by reaching deeper trigger points.
With this hypothesis, we aimed to investigate the contribution of the erector spina plane block to trigger point injection in the treatment of myofascial pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Myofascial pain syndrome is a common chronic disease characterized by pain and tenderness in one or more muscle groups.
It is characterized by myofascial trigger points that are felt as a band or a nodule harder than normal consistency located in the muscle.
Myofascial trigger points are developes as a result of muscle injury ; this can be acute trauma caused by sport injury, accident, or chronic muscle overuse by repetitive occupational activities, emotional stress or poor posture.
Trigger point injection is the application of low dose local anesthetic drug into the trigger point.Its main purpose is to weaken the trigger point caused by muscle spasm.However, it may reduce pain partially or have a short duration of action, so it may need to be repeated several times at regular intervals.Trigger point injection can reach trigger points in superficial muscles With the erector spina plane block technique, more effective and long-term pain treatment can be achieved by reaching deeper trigger points.
With this hypothesis, we aimed to investigate the contribution of the erector spina plane block to trigger point injection in the treatment of myofascial pain.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey
- Dişkapi Reserch and Education Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Clinical diagnosis of Myofascial pain
Exclusion Criteria:
Cervical radiculopathy fibromyalgia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Trapezius Muscle İnjection (TMI) group
TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.
Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections
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TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.
|
|
Active Comparator: Erector Spina Plane Block (ESPB) group
ESPB group in the 1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive.
Pain severity of the patients will evaluate by visual analog scale before (week 0) and after (week 1,2,3,4) the injections
|
TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.
1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS (visual analog scale ) score
Time Frame: before injection (week 0)
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Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
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before injection (week 0)
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VAS (visual analog scale ) score
Time Frame: 1st week after injection
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Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
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1st week after injection
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VAS (visual analog scale ) score
Time Frame: 2nd week after injection
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Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
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2nd week after injection
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VAS (visual analog scale ) score
Time Frame: 3rd week after injection
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Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
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3rd week after injection
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VAS (visual analog scale ) score
Time Frame: 4th weeks after injection
|
Severity of pain The patient rated pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.
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4th weeks after injection
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: damla yürük, Diskapi Teaching and Research Hospital
- Study Director: ömer taylan akkaya, Diskapi Teaching and Research Hospital
- Study Chair: Hüseyin Alp Alptekin, Diskapi Teaching and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
July 5, 2020
Study Completion (Actual)
July 20, 2020
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 27, 2020
First Posted (Actual)
May 28, 2020
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiskapiTRH Algology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
IPD Sharing Time Frame
19.05.2020
IPD Sharing Access Criteria
NO CRİTERİA
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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