NCT05888285

Brief Summary

ESP is the deepest back muscle originating from the transverse processes of the vertebrae. Blocks applied to this region are effective for a longer time and in the broader area than those applied to superficial muscles. Recently, pulsed radiofrequency treatments have also been performed in myofascial pain, and successful results have been obtained. The investigators aim to investigate whether there is a difference between these two applications in terms of treatment efficacy.

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 Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

May 15, 2023

Last Update Submit

June 1, 2023

Conditions

Back PainBlockPain, Muscle

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.

    Change from Baseline VAS at third months.

Secondary Outcomes (1)

  • Centrality of pain Scale

    Before treatment

Study Arms (2)

ESP Block

ACTIVE COMPARATOR

ESP block for back pain treatment is applied

Procedure: Erector spina plane block

ESP RFT

ACTIVE COMPARATOR

ESP block and pulsed radiofrequency for back pain treatment is applied

Procedure: Erector spina bale block and pulsed radiofrequency

Interventions

Erector spina plane blockPROCEDURE

The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection

ESP Block
Erector spina bale block and pulsed radiofrequencyPROCEDURE

The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection and pulsed radiofrequency treatment

ESP RFT

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • myofascial pain
  • normal thoracic examination

You may not qualify if:

  • additional cardiac disease
  • lung disease
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gevher Rabia Genç Perdecioğlu

Ankara, Umit Province, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back PainBites and StingsMyalgia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPoisoningChemically-Induced DisordersWounds and InjuriesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 5, 2023

Study Start

January 1, 2023

Primary Completion

May 1, 2023

Study Completion

May 14, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations

TU(1)