NCT05073900

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

September 29, 2021

Last Update Submit

November 25, 2021

Conditions

Myofascial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline to minutes 30, day 1, week 1, 2, 4, 6 after the block

Study Arms (2)

Rhomboid intercostal block

EXPERIMENTAL

Ultrasound guided rhomboid intercostal block

Procedure: Rhomboid intercostal block

Erector spinae plane block

ACTIVE COMPARATOR

Ultrasound guided erector spinae plane block

Procedure: Rhomboid intercostal block

Interventions

Rhomboid intercostal blockPROCEDURE

two regional anesthesia block techniques are applied

Also known as: Erector spinae plane block
Erector spinae plane blockRhomboid intercostal block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • selin guven kose

    Diskapi Teaching and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

July 10, 2021

Primary Completion

September 10, 2021

Study Completion

October 24, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations

TU(1)