Pain, ChronicNCT05062993
Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain
A study testing caudal epidural pulse radio frequency in people with Pain, Chronic, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- caudal epidural pulse radio frequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2021to 1 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic pain in legs or back pain
- unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections
Who cannot join
- coagulation disorders
- psychiatric disorders
- rheumatoid disorders
- infections
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
About this study
Official title: Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome
Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.
- Conditions
- Pain, Chronic
- Being tested
- caudal epidural pulse radio frequency
- Keywords
- caudal epidural stimulation, chronic pain, lumbosacral radiculopathy, postlumbar surgery syndrome
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal epidural pulse radio frequencyProcedure or surgery
A needle is inserted into the caudal epidural space under ultrasound guidance and pulse radiofrequency is administered at 5 Hz using a 5. ms pulse width for 600 seconds at 55 V.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Patients with chronic radicular pain will be included in this study. Ultrasound guided caudal epidural pulse radiofrequency technique will be applied to the study group. Receives: Procedure: caudal epidural pulse radio frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale(NRS) (0-10)
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Measured: before procedure
Numeric Rating Scale
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Measured: 2 weeks after procedure
Numeric Rating Scale
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Measured: 4 weeks after procedure
Numeric Rating Scale
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Measured: 8 weeks after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start22 Feb 2021
- Primary completion1 May 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Guven Kose, Diskapi Teaching and Research Hospital
- Investigators
- Selin Guven Kose, Principal investigator, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062993
- Sponsor's protocol ID
- 98/08
- Status last verified
- Jan 2022
- First submitted
- 7 Jul 2021
- Last updated
- 7 Feb 2022
- 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Ultrasound Guided Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain in Patients With Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT05062993
- Acronym / sponsor ID
- 98/08
- Conditions
- Pain, Chronic
- Keywords
- caudal epidural stimulation, chronic pain, lumbosacral radiculopathy, postlumbar surgery syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 30 Sep 2021 (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.
Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery. The recently introduced pulsed radiofrequency (PRF) technique is widely used to provide relief from chronic pain and studies have shown that PRF stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space The aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: caudal epidural pulse radio frequencyPatients with chronic radicular pain will be included in this study. Ultrasound guided caudal epidural pulse radiofrequency technique will be applied to the study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic pain in legs or back pain
- unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections
Key exclusion criteria (4 listed)
- coagulation disorders
- psychiatric disorders
- rheumatoid disorders
- infections
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 |
|---|---|---|
| caudal epidural pulse radio frequencyA needle is inserted into the caudal epidural space under ultrasound guidance and pulse radiofrequency is administered at 5 Hz using a 5. ms pulse width for 600 seconds at 55 V. | Procedure or surgery | study group |
Primary outcome
Numeric Rating Scale(NRS) (0-10)
Time frame: before procedure
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Numeric Rating Scale
Time frame: 2 weeks after procedure
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Numeric Rating Scale
Time frame: 4 weeks after procedure
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Numeric Rating Scale
Time frame: 8 weeks after procedure
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
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 7 Feb 2022.
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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.
Selin Guven Kose principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caudal epidural pulse radio frequency in people with Pain, Chronic, 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 4 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 7 Feb 2022. 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?
Numeric Rating Scale(NRS) (0-10) (time frame: before procedure). The study lists 4 primary outcomes in all. 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 7 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.