Back PainNCT06239857
Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome
A study testing Epidural pulsed radiofrequency in people with Back Pain and Failed Back Surgery Syndrome, run by Başakşehir Çam & Sakura City Hospital.
Trial summary
Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. A component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Failed Back Surgery Syndrome, Neuropathic Pain
- What is being tested?
- Epidural pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to 30 Jul 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-80
- History of at least one operation due to lumbar disc herniation
- Having radicular pain radiating to the lower extremities
Who cannot join
- Having undergone surgery for an etiology other than lumbar disc herniation
- Accompanying spinal stenosis and spondylolisthesis
- Presence of fracture, infection, coagulopathy and pregnancy
- Mental disorders that may negatively affect cooperation during assessments.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Epidural Pulsed Radiofrequency Treatment on Pain in Patients Diagnosed With Failed Back Surgery Syndrome (Persistant Spinal Pain Syndrome)
Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. A component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. Low back pain and radicular pain in the lower extremities are the main symptoms of failed back surgery syndrome (also called persistent spinal pain syndrome in new terminology).
There are many methods for treatment of failed back surgery syndrome, such as analgesic medications, physical therapy, interventional pain treatment applications, and re-surgery options. Epidural pulsed radiofrequency therapy has recently become popular among interventional pain management procedures, and studies on its effectiveness are increasing. However, studies with a multifaceted approach that also evaluate neuropathic pain are lacking in the literature. In this study, it was planned to investigate the effect of epidural pulsed radiofrequency therapy on pain palliation, including neuropathic pain, in patients diagnosed with failed back surgery syndrome.
- Conditions
- Back Pain, Failed Back Surgery Syndrome, Neuropathic Pain
- Being tested
- Epidural pulsed radiofrequency
- Medical subject headings
- Back Pain, Failed Back Surgery Syndrome, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural pulsed radiofrequencyProcedure or surgery
The radiofrequency treatment is applied under sterile conditions in the operating room environment. The target epidural area is reached under fluoroscopy guidance using a radiofrequency needle. After control of the needle position, radiofrequency treatment is given. Radiofrequency parameters are set as maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.
| Study group | Role | What they receive |
|---|---|---|
| Epidural pulsed radiofrequency treatment | Experimental | All patients diagnosed with failed back surgery syndrome will receive epidural pulsed radiofrequency treatment. Receives: Procedure: Epidural pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity score
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Measured: A single point in time (pre-procedural time)
Change in pain severity score
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Measured: A single point in time (post-procedural 1.month)
Change in pain severity score
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Measured: A single point in time (post-procedural 3.month)
Change in pain severity score
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Measured: A single point in time (post-procedural 6.month)
Change in pain severity score
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Measured: A single point in time (post-procedural 12.month)
Change in the number of patients with neuropathic pain
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Measured: A single point in time (pre-procedural time)
Change in the number of patients with neuropathic pain
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Measured: A single point in time (post-procedural 1.month)
Change in the number of patients with neuropathic pain
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Measured: A single point in time (post-procedural 3.month)
Change in the number of patients with neuropathic pain
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Measured: A single point in time (post-procedural 6.month)
Change in the number of patients with neuropathic pain
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Measured: A single point in time (post-procedural 12.month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start15 Feb 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Erken, Başakşehir Çam & Sakura City Hospital
- Investigators
- Günay Yolcu, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239857
- Sponsor's protocol ID
- 27.12.2023.700
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erken B, Yolcu G, Saracoglu TT. Efficacy of Epidural Pulsed Radiofrequency Treatment in Persistent Spinal Pain Syndrome: A Prospective Clinical Study. Pain Res Manag. 2025 Apr 11;2025:6200102. doi: 10.1155/prm/6200102. eCollection 2025.
PubMed 40255928
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Epidural Pulsed Radiofrequency Treatment on Pain in Patients Diagnosed With Failed Back Surgery Syndrome (Persistant Spinal Pain Syndrome)
- ClinicalTrials.gov ID
- NCT06239857
- Acronym / sponsor ID
- 27.12.2023.700
- Conditions
- Back Pain, Failed Back Surgery Syndrome, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. A component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. Low back pain and radicular pain in the lower extremities are the main symptoms of failed back surgery syndrome (also called persistent spinal pain syndrome in new terminology).
There are many methods for treatment of failed back surgery syndrome, such as analgesic medications, physical therapy, interventional pain treatment applications, and re-surgery options. Epidural pulsed radiofrequency therapy has recently become popular among interventional pain management procedures, and studies on its effectiveness are increasing. However, studies with a multifaceted approach that also evaluate neuropathic pain are lacking in the literature. In this study, it was planned to investigate the effect of epidural pulsed radiofrequency therapy on pain palliation, including neuropathic pain, in patients diagnosed with failed back 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 |
|---|---|---|
| Epidural pulsed radiofrequency treatment | Experimental | Procedure: Epidural pulsed radiofrequencyAll patients diagnosed with failed back surgery syndrome will receive epidural pulsed radiofrequency treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-80
- History of at least one operation due to lumbar disc herniation
- Having radicular pain radiating to the lower extremities
Key exclusion criteria (4 listed)
- Having undergone surgery for an etiology other than lumbar disc herniation
- Accompanying spinal stenosis and spondylolisthesis
- Presence of fracture, infection, coagulopathy and pregnancy
- Mental disorders that may negatively affect cooperation during assessments.
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 |
|---|---|---|
| Epidural pulsed radiofrequencyThe radiofrequency treatment is applied under sterile conditions in the operating room environment. The target epidural area is reached under fluoroscopy guidance using a radiofrequency needle. After control of the needle position, radiofrequency treatment is given. Radiofrequency parameters are set as maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds. | Procedure or surgery | Epidural pulsed radiofrequency treatment |
Primary outcome
Change in pain severity score
Time frame: A single point in time (pre-procedural time)
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Change in pain severity score
Time frame: A single point in time (post-procedural 1.month)
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Change in pain severity score
Time frame: A single point in time (post-procedural 3.month)
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Change in pain severity score
Time frame: A single point in time (post-procedural 6.month)
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Change in pain severity score
Time frame: A single point in time (post-procedural 12.month)
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Change in the number of patients with neuropathic pain
Time frame: A single point in time (pre-procedural time)
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Change in the number of patients with neuropathic pain
Time frame: A single point in time (post-procedural 1.month)
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Change in the number of patients with neuropathic pain
Time frame: A single point in time (post-procedural 3.month)
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Change in the number of patients with neuropathic pain
Time frame: A single point in time (post-procedural 6.month)
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Change in the number of patients with neuropathic pain
Time frame: A single point in time (post-procedural 12.month)
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Derived from this study: PubMed 40255928Erken B, Yolcu G, Saracoglu TT. Efficacy of Epidural Pulsed Radiofrequency Treatment in Persistent Spinal Pain Syndrome: A Prospective Clinical Study. Pain Res Manag. 2025 Apr 11;2025:6200102. doi: 10.1155/prm/6200102. eCollection 2025.
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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.
Günay Yolcu, MD principal investigator
Başakşehir Çam & Sakura City Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Epidural pulsed radiofrequency in people with Back Pain and Failed Back Surgery Syndrome, run by Başakşehir Çam & Sakura City Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burak Erken, MD (+902129096000, burak_erken@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity score (time frame: A single point in time (pre-procedural time)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239857, which also lists 1 linked publication.
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 2 Feb 2024.