Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome

November 25, 2021 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital

Comparison of the Efficacy of Ultrasound Guided Rhomboid Intercostal Block and Erector Spinal Plane Block on Lower Cervical and Interscapular Myofascial Pain Syndrome

The investigators evaluate the effect of Ultrasound guided Rhomboid Intercostal Block and Erector Spinal Plane Block on lower cervical and inter scapular Myofascial Pain

Study Overview

Status

Completed

Detailed Description

Myofascial pain syndrome (MPS) is the most common cause of musculoskeletal pain and its prevalence in the population is reported to be 21-30%. In this study, the investigators compare the effect of two regional anesthesia block techniques with the ultrasound guidance.

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

      • Ankara, Turkey, 06110
        • Diskapi Yildirim Beyazit Training and Research 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complaint of myofascial pain
  • Pain that is rated at least 3 on a numerical rating scale (NRS, 0 = no pain, 10 = the worst pain)

Exclusion Criteria:

  • pregnancy
  • presence of coagulopathy, or the use of anticoagulants
  • a history of surgery on the block area
  • allergic to bupivacaine
  • decline to participate

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rhomboid intercostal block
Ultrasound guided rhomboid intercostal block
two regional anesthesia block techniques are applied
Other Names:
  • Erector spinae plane block
Active Comparator: Erector spinae plane block
Ultrasound guided erector spinae plane block
two regional anesthesia block techniques are applied
Other Names:
  • Erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS)
Time Frame: Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
Pain Score Change The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block

Collaborators and Investigators

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

Investigators

  • Principal Investigator: selin guven kose, 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)

July 10, 2021

Primary Completion (Actual)

September 10, 2021

Study Completion (Actual)

October 24, 2021

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

October 11, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

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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