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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Ankara, Turkey
        • Dişkapi Reserch and Education Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Procedure: trapezius muscle injection
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
Procedure: trapezius muscle injection
TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.
Procedure: erector spina plane block
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VAS (visual analog scale ) score
Time Frame: before injection (week 0)
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.
before injection (week 0)
VAS (visual analog scale ) score
Time Frame: 1st week 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.
1st week after injection
VAS (visual analog scale ) score
Time Frame: 2nd week 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.
2nd week after injection
VAS (visual analog scale ) score
Time Frame: 3rd week 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.
3rd week after injection
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.
4th weeks after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Diskapi Teaching and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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