Erector Spina Plane Block and Radiofrequency Treatmen

Back Pain Clinical Trial

Official title:

Is Radiofrequency Necessary in Myofascial Pain?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05888285
• Other study ID #: ESP Block VS ESP RF
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 14, 2023

Study information

• Verified date: June 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 14, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• myofascial pain

• normal thoracic examination

Exclusion Criteria:

• additional cardiac disease

• lung disease

• malignancy

Related Conditions & MeSH terms

• Back Pain
• Block
• Myalgia
• Pain, Muscle

Intervention

Procedure:
• Erector spina plane block
The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection
• 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

Locations

Country	Name	City	State
Turkey	Gevher Rabia Genç Perdecioglu	Ankara	Umit Province

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Centrality of pain Scale	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.	Before treatment