Back PainNCT05888285
Erector Spina Plane Block and Radiofrequency Treatmen
A study testing Erector spina plane block and Erector spina bale block and pulsed radiofrequency in people with Back Pain and Block, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain, Block, Pain, Muscle
- What is being tested?
- Erector spina plane block and Erector spina bale block and pulsed radiofrequency
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 14 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- myofascial pain
- normal thoracic examination
Who cannot join
- additional cardiac disease
- lung disease
- malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gevher Rabia Genç Perdecioğlu
Ankara, Umit Province, 20000
About this study
Official title: Is Radiofrequency Necessary in Myofascial Pain?
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.
- Conditions
- Back Pain, Block, Pain, Muscle
- Being tested
- Erector spina plane block, Erector spina bale block and pulsed radiofrequency
- Medical subject headings
- Back Pain, Bites and Stings, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spina plane blockProcedure or surgery
The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection
Erector spina bale block and pulsed radiofrequencyProcedure or surgery
The transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection and pulsed radiofrequency treatment
| Study group | Role | What they receive |
|---|---|---|
| ESP Block | Active comparator | ESP block for back pain treatment is applied Receives: Procedure: Erector spina plane block |
| ESP RFT | Active comparator | ESP block and pulsed radiofrequency for back pain treatment is applied Receives: Procedure: Erector spina bale block and pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Measured: 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.
Measured: Before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jan 2023
- Primary completion1 May 2023
- Study completion14 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888285
- Sponsor's protocol ID
- ESP Block VS ESP RF
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Radiofrequency Necessary in Myofascial Pain?
- ClinicalTrials.gov ID
- NCT05888285
- Acronym / sponsor ID
- ESP Block VS ESP RF
- Conditions
- Back Pain, Block, Pain, Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 14 May 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Block | Active comparator | Procedure: Erector spina plane blockESP block for back pain treatment is applied |
| ESP RFT | Active comparator | Procedure: Erector spina bale block and pulsed radiofrequencyESP block and pulsed radiofrequency for back pain treatment is applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- myofascial pain
- normal thoracic examination
Key exclusion criteria (3 listed)
- additional cardiac disease
- lung disease
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spina plane blockThe transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection | Procedure or surgery | ESP Block |
| Erector spina bale block and pulsed radiofrequencyThe transverse processes of the thoracic vertebrae are treated with ultrasound-guided drug injection and pulsed radiofrequency treatment | Procedure or surgery | ESP RFT |
Primary outcome
Visual analog scale
Time frame: 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.
1 secondary outcome
Centrality of pain Scale
Time frame: Before treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spina plane block and Erector spina bale block and pulsed radiofrequency in people with Back Pain and Block, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: Change from Baseline VAS at third months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.