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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural pulsed radiofrequency treatment | Experimental | All patients diagnosed with failed back surgery syndrome will receive epidural pulsed radiofrequency treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural pulsed radiofrequency | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | A single point in time (post-procedural 12.month) |
| Change in the number of patients with neuropathic pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Burak Erken, MD | Contact | +902129096000 | burak_erken@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Günay Yolcu, MD | Başakşehir Çam & Sakura City Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40255928 | Derived | 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. |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D055111 | Failed Back Surgery Syndrome |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| 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. | 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. | 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. | 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. | A single point in time (post-procedural 12.month) |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |