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Contribution of Erector Spina Plane Block to Analgesia for Myofascial Pain Syndrome

Primary Purpose

Trigger Point, Myofascial Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
trapezius muscle injection
erector spina plane block
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point focused on measuring Trigger point , Erector spinae plane block , Ultrasonography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of Myofascial pain

Exclusion Criteria:

Cervical radiculopathy fibromyalgia

Sites / Locations

  • Dişkapi Reserch and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trapezius Muscle İnjection (TMI) group

Erector Spina Plane Block (ESPB) group

Arm Description

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

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

Outcomes

Primary Outcome Measures

VAS (visual analog scale ) score
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.
VAS (visual analog scale ) score
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.
VAS (visual analog scale ) score
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.
VAS (visual analog scale ) score
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.
VAS (visual analog scale ) score
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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2020
Last Updated
August 18, 2020
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04405453
Brief Title
Contribution of Erector Spina Plane Block to Analgesia for Myofascial Pain Syndrome
Official Title
Contribution of Erector Spina Plane Block to Analgesia Combined With Ultrasound Guided Trapezius Muscle Injection for Myofascial Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 5, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point, Myofascial Pain
Keywords
Trigger point , Erector spinae plane block , Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Patients with myofasial pain syndrome will randomized into two group. TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval. 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. Datas will obtaine before (week 0) and after (week 1,2,3,4) the injections.
Masking
Investigator
Masking Description
One physician who will be blind will examinade all patients for eligibility and will valuate the outcome measures although the physician who will performe all injections will not be blind.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trapezius Muscle İnjection (TMI) group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Erector Spina Plane Block (ESPB) group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
trapezius muscle injection
Intervention Description
TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.
Intervention Type
Procedure
Intervention Name(s)
erector spina plane block
Intervention Description
1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive
Primary Outcome Measure Information:
Title
VAS (visual analog scale ) score
Description
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.
Time Frame
before injection (week 0)
Title
VAS (visual analog scale ) score
Description
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.
Time Frame
1st week after injection
Title
VAS (visual analog scale ) score
Description
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.
Time Frame
2nd week after injection
Title
VAS (visual analog scale ) score
Description
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.
Time Frame
3rd week after injection
Title
VAS (visual analog scale ) score
Description
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.
Time Frame
4th weeks after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Myofascial pain Exclusion Criteria: Cervical radiculopathy fibromyalgia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
damla yürük
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ömer taylan akkaya
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hüseyin Alp Alptekin
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dişkapi Reserch and Education Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Contribution of Erector Spina Plane Block to Analgesia for Myofascial Pain Syndrome

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