ClinicalTrials.gg
CompletedNCT05888285Updated Jun 5, 2023

Erector Spina Plane Block and Radiofrequency Treatmen

An interventional study of Erector spina plane block and Erector spina bale block and pulsed radiofrequency in Back Pain, Block and Pain, Muscle, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by Diskapi Teaching and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2023, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Back Pain
  • Block
  • Pain, Muscle
03

In context

Back Pain

2,389 studies on the registry are indexed under Back Pain; 282 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 1,952 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 106 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • myofascial pain
  • normal thoracic examination

Exclusion criteria

Exclusion Criteria:

  • additional cardiac disease
  • lung disease
  • malignancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    ESP Block

    ESP block for back pain treatment is applied

    Procedure: Erector spina plane block

  • Active comparator
    ESP RFT

    ESP block and pulsed radiofrequency for back pain treatment is applied

    Procedure: Erector spina bale block and pulsed radiofrequency

Interventions

  • ProcedureErector spina plane block

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

  • ProcedureErector spina bale block and pulsed radiofrequency

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

06

What researchers measure

Primary outcomes

  1. Visual analog scale

    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 outcomes

  1. 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.

    Time frame: Before treatment

07

Study locations

1 site
  • Gevher Rabia Genç Perdecioğlu
    Ankara, Umit Province 20000, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in May 2023, 4 months.

Of 933 non-industry interventional studies with no phase under Back Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's 4 months is below that.

Counting every sponsor, half of 997 studies reached it within 11 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2023
First posted
Jun 5, 2023
StartActual
Jan 1, 2023
Primary completionActual
May 1, 2023
CompletionActual
May 14, 2023
Last update
Jun 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05888285
Responsible party
Damla Yürük (Director, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Jun 5, 2023
Start date
Jan 1, 2023
Primary completion
May 1, 2023
Completion
May 14, 2023
Last update
Jun 5, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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