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Erector Spina Plane Block and Radiofrequency Treatmen

Primary Purpose

Back Pain, Block, Pain, Muscle

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spina plane block
Erector spina bale block and pulsed radiofrequency
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: myofascial pain normal thoracic examination Exclusion Criteria: additional cardiac disease lung disease malignancy

Sites / Locations

  • Gevher Rabia Genç Perdecioğlu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESP Block

ESP RFT

Arm Description

ESP block for back pain treatment is applied

ESP block and pulsed radiofrequency for back pain treatment is applied

Outcomes

Primary Outcome Measures

Visual analog scale
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
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.

Full Information

First Posted
May 15, 2023
Last Updated
June 1, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05888285
Brief Title
Erector Spina Plane Block and Radiofrequency Treatmen
Official Title
Is Radiofrequency Necessary in Myofascial Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Block, Pain, Muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP Block
Arm Type
Active Comparator
Arm Description
ESP block for back pain treatment is applied
Arm Title
ESP RFT
Arm Type
Active Comparator
Arm Description
ESP block and pulsed radiofrequency for back pain treatment is applied
Intervention Type
Procedure
Intervention Name(s)
Erector spina plane block
Intervention Description
The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection
Intervention Type
Procedure
Intervention Name(s)
Erector spina bale block and pulsed radiofrequency
Intervention Description
The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection and pulsed radiofrequency treatment
Primary Outcome Measure Information:
Title
Visual analog scale
Description
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Time Frame
Change from Baseline VAS at third months.
Secondary Outcome Measure Information:
Title
Centrality of pain Scale
Description
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.
Time Frame
Before treatment

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: myofascial pain normal thoracic examination Exclusion Criteria: additional cardiac disease lung disease malignancy
Facility Information:
Facility Name
Gevher Rabia Genç Perdecioğlu
City
Ankara
State/Province
Umit Province
ZIP/Postal Code
20000
Country
Turkey

12. IPD Sharing Statement

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