Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome
Primary Purpose
Myofascial Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rhomboid intercostal block
Sponsored by
About this trial
This is an interventional prevention trial for Myofascial Pain Syndrome
Eligibility Criteria
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
Sites / Locations
- Diskapi Yildirim Beyazit Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rhomboid intercostal block
Erector spinae plane block
Arm Description
Ultrasound guided rhomboid intercostal block
Ultrasound guided erector spinae plane block
Outcomes
Primary Outcome Measures
Numerical Rating Scale (NRS)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05073900
First Posted
September 29, 2021
Last Updated
November 25, 2021
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05073900
Brief Title
Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome
Official Title
Comparison of the Efficacy of Ultrasound Guided Rhomboid Intercostal Block and Erector Spinal Plane Block on Lower Cervical and Interscapular Myofascial Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
October 24, 2021 (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
The investigators evaluate the effect of Ultrasound guided Rhomboid Intercostal Block and Erector Spinal Plane Block on lower cervical and inter scapular Myofascial Pain
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rhomboid intercostal block
Arm Type
Experimental
Arm Description
Ultrasound guided rhomboid intercostal block
Arm Title
Erector spinae plane block
Arm Type
Active Comparator
Arm Description
Ultrasound guided erector spinae plane block
Intervention Type
Procedure
Intervention Name(s)
Rhomboid intercostal block
Other Intervention Name(s)
Erector spinae plane block
Intervention Description
two regional anesthesia block techniques are applied
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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.
Time Frame
Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
selin guven kose
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy of Rhomboid Intercostal Block and Erector Spinal Plane Block on Myofascial Pain Syndrome
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