Erector Spina Plane Block and Radiofrequency Treatmen

Sponsor

Diskapi Teaching and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05888285

Collaborator

(none)

Enrollment

Location

Arms

4.4

Actual Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain Block Pain, Muscle	Procedure: Erector spina plane block Procedure: Erector spina bale block and pulsed radiofrequency	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Is Radiofrequency Necessary in Myofascial Pain?

Actual Study Start Date :

Jan 1, 2023

Actual Primary Completion Date :

May 1, 2023

Actual Study Completion Date :

May 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ESP Block ESP block for back pain treatment is applied	Procedure: Erector spina plane block The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection
Active Comparator: ESP RFT ESP block and pulsed radiofrequency for back pain treatment is applied	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

Arm

Intervention/Treatment

Active Comparator: ESP Block

ESP block for back pain treatment is applied

Procedure: Erector spina plane block

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

Active Comparator: ESP RFT

ESP block and pulsed radiofrequency for back pain treatment is applied

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

Outcome Measures

Primary Outcome Measures

Visual analog scale [Change from Baseline VAS at third months.]
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.

Secondary Outcome Measures

Centrality of pain Scale [Before treatment]
The Centrality of Pain Scale (COPS) is a 10-item self-report measure designed to assess. Each item is scored on a 5-point Likert scale where 1=strongly disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=strongly agree. Three items are reverse scored the extent to which pain dominates a patient's life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

myofascial pain
normal thoracic examination

Exclusion Criteria:

additional cardiac disease
lung disease
malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gevher Rabia Genç Perdecioğlu	Ankara	Umit Province	Turkey	20000

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Damla Yürük, Director, Diskapi Teaching and Research Hospital

ClinicalTrials.gov Identifier:

NCT05888285

Other Study ID Numbers:

ESP Block VS ESP RF

First Posted:

Jun 5, 2023

Last Update Posted:

Jun 5, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myalgia

Study Results

No Results Posted as of Jun 5, 2023