Erector Spina Plane Block and Radiofrequency Treatmen

NCT ID: NCT05888285

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Trigger point injections and erector spina planus muscle (ESP) blocks are used to treat back pain related to myofascial pain syndrome. 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.

Deep and superficial back muscles, transverse processes of the vertebrae, costume, and pleural movement are identified by ultrasonographic examination. The investigators perform the intervention through the transverse processes. The investigators give 20 ccs of fluid (bupivacaine, steroids, saline). The patients to whom The investigators apply pulsed radiofrequency complete the procedure by giving 20 ccs of fluid after the radiofrequency application on the transverse processes and during the procedure, using 10 cm, 21 gauge radiofrequency needles with an active tip of 10 mm. The radiofrequency wave is applied at 2 Hz, ten milliseconds, and 55 volts for 5+5 for 10 minutes.

The investigators aim to investigate whether there is a difference between these two applications in terms of treatment efficacy. For this reason, the Visual Pain Scale of each patient will be recorded before the procedure, the second week after the procedure, and the first month. The Centrality of Pain Scale will be applied to these patients at the controls. The correlation between the results of this scale, which evaluates the emotional and physical state of the patients, and the post-treatment pain scales will be evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Back Pain Block Pain, Muscle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ESP Block

ESP block for back pain treatment is applied

Group Type ACTIVE_COMPARATOR

Erector spina plane block

Intervention Type PROCEDURE

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

ESP RFT

ESP block and pulsed radiofrequency for back pain treatment is applied

Group Type ACTIVE_COMPARATOR

Erector spina bale block and pulsed radiofrequency

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erector spina plane block

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

Intervention Type PROCEDURE

Erector spina bale block and pulsed radiofrequency

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* myofascial pain
* normal thoracic examination

Exclusion Criteria

* additional cardiac disease
* lung disease
* malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Damla Yürük

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gevher Rabia Genç Perdecioğlu

Ankara, Umit Province, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ESP Block VS ESP RF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.