Back PainNCT07497269
Conventional vs Pulsed RF in Coccydynia
A study testing Pulsed Radiofrequency and Conventional Radiofrequency in people with Back Pain, run by Adana City Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to prospectively evaluate the effects of pulsed and conventional radiofrequency ablation of the ganglion impar on pain, quality of life, and sleep quality in patients with refractory coccydynia, and to determine whether one treatment is superior to the other. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Pulsed Radiofrequency and Conventional Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Chronic pain in the coccygeal region lasting longer than 3 months, unresponsive to analgesics, anti-inflammatory drugs, and other conservative treatment methods.
- Patients scheduled to undergo ganglion impar treatment with either conventional or pulsed radiofrequency ablation (RFA).
Who cannot join
- Incomplete medical records.
- Loss to follow-up.
- Technical failure during the block procedure.
- Local infection, bleeding disorders, allergy to contrast agents, or history of spinal surgery.
- History of malignancy.
- Refusal to participate in the study.
Show all 9Show fewer
- Diagnosed psychological disorders.
- Individuals unable to communicate effectively or understand instructions.
- Age under 18 or over 80 years.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Adana City Training and Research Hospital
Adana, Adana
Derya Bayram, 05433400430, deryak.bayram@gmail.com
- Recruiting
Tobb Etü Hospital
Ankara, Ankara
Dostali Aliyev, MD, +905514351936, dr.dostalialiyev@gmail.com
Derya Bayram, MD, +905433400430, deryak.bayram@gmail.com
About this study
Official title: Pulsed vs Conventional Radiofrequency of the Ganglion Impar for Coccydynia: A Prospective Randomized Trial
The aim of this study is to prospectively evaluate the effects of pulsed and conventional radiofrequency ablation of the ganglion impar on pain, quality of life, and sleep quality in patients with refractory coccydynia, and to determine whether one treatment is superior to the other.
Read the detailed description
Coccydynia, commonly referred to as tailbone pain, is a persistent pain condition targeting the coccyx, a small triangular bone located at the lower end of the spine. The main cause of this pain is usually abnormal movement in the coccygeal region, which leads to continuous inflammation. Coccydynia more commonly affects women than men and is often associated with obesity. Although it most frequently occurs around the age of 40, it can be seen in individuals of all ages. The origins of coccydynia are varied, including both physical and psychological factors. The main physical causes are trauma from falling onto the buttocks, repetitive minor injuries, or childbirth, which are the most common triggers. Non-traumatic causes of coccydynia include degenerative diseases of the joints or discs, abnormal movements in the sacrococcygeal joint, obesity, infections, changes in the shape of the coccyx, or cancers in the pelvic or anorectal regions. The effectiveness of treatments for coccydynia varies considerably.
Several conservative treatment options exist for coccydynia, such as nonsteroidal anti-inflammatory drugs (NSAIDs), local analgesics, hot or cold applications, transcutaneous electrical nerve stimulation (TENS), specially designed wedge-shaped cushions (coccygeal cushions), and exercises aimed at relaxing the levator ani muscle. These methods aim to reduce pain and inflammation and improve the functionality of the coccyx and surrounding muscles. When these conservative approaches fail to provide relief, more invasive procedures may be considered. Techniques such as direct local anesthetic injections to the coccyx, coccygeal nerve blocks, caudal epidural injections, and ganglion impar blocks offer minimally invasive alternatives for coccydynia treatment. Among the methods for impar ganglion blocks, pulsed RF, thermocoagulation ablation techniques, and neurolytic techniques are considered treatments that provide long-term pain palliation. The transacrococcygeal technique for impar ganglion block is an easy and safe method. This technique allows neurolysis or radiofrequency thermocoagulation ablation of the impar ganglion and can be used for diagnostic blocks depending on the response to initial diagnostic injections.
The ganglion impar (Walther ganglion) is a single sympathetic ganglion formed by the convergence of the distal ends of the lumbosacral sympathetic chains. It is the lowest ganglion of the sympathetic nervous system. Being single and medial (unlike the paired paravertebral sympathetic ganglia), it is the only solitary sympathetic ganglion. It is located retroperitoneally, anterior to the sacrum, at the level of the sacrococcygeal symphysis, and posterior to the rectum. It provides sympathetic efferent fibers and receives afferent sensory information from many pelvic structures, supplying sympathetic and nociceptive innervation to the perineum, coccyx, anus, distal rectum, vulva, urethra, and vagina. Interventions on the ganglion impar disrupt afferent sympathetic and nociceptive pathways from the pelvis, perineum, and anal region. Interventions on the ganglion impar can be performed using various agents and techniques, including local anesthetics, corticosteroids, ethanol, phenol, botulinum toxin, radiofrequency ablation (RFA) or modulation (RFM), and cryoablation. The transsacrococcygeal technique is more commonly used. Numerous technique variations exist, but the goal is to successfully direct the needle to the anterior surface of the coccyx or sacrococcygeal symphysis to deliver local anesthetics, steroids, or neurolytic agents without damaging pelvic bones or organs. Radiopaque contrast is injected to visualize proper retroperitoneal distribution of the agent along the anterior surface of the coccyx.
Visceral pain mediated by sympathetic fibers in the perineal region can be effectively treated by neurolysis of the impar ganglion. Theoretically, this procedure can also be applied for pain due to malignancy, endometriosis, complex regional pain syndrome, prostate pain, radiation-induced enteritis, postherpetic neuralgia, and refractory coccydynia. The use of sympathetic chain ablation for persistent pain in the sacral-pelvic region differs from other targets, because the anatomical variation of the impar ganglion requires careful combination of radiofrequency thermocoagulation and neurolytic agents (alcohol or phenol) to maximize pain control. When using the thermocoagulation radiofrequency ablation technique, special equipment such as electrostimulation devices and minute controllers are required. Therefore, selective destruction of nerve fibers is possible, and the size and location of the lesion can be controlled, resulting in a lower risk of complications.
The effects of conventional radiofrequency (CRF) thermocoagulation for chronic coccydynia were retrospectively analyzed (patients unresponsive to conservative treatment and local injections for 6 months. Ten patients who responded to diagnostic block with 10 mL of 0.25% bupivacaine underwent CRF treatment. Approximately 90% of patients achieved successful results at 6 months, defined as a 50% reduction in VAS scores. Transcoccygeal/intercoccygeal CRF of the ganglion impar is simple, relatively safe, and should be considered for chronic coccydynia unresponsive to conservative therapy for 6 months. Similar findings were observed by another study in a retrospective analysis of CRF in 20 patients with chronic refractory coccydynia.
No previous study has compared the superiority of these two routinely applied long-term coccyx pain treatments.
- Conditions
- Back Pain
- Being tested
- Pulsed Radiofrequency, Conventional Radiofrequency
- Keywords
- Radiofrequency Ablation, low back pain, quality of life, coccyx
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed RadiofrequencyProcedure or surgery
Once the needle is properly positioned along the sacrococcygeal disc line, 1 mL of radiopaque contrast is injected. The needle placement is confirmed in the lateral fluoroscopic view as a comma-shaped spread in the retroperitoneal space.
Radiofrequency interventions on the ganglion impar are performed using a radiofrequency generator. A 22G radiofrequency needle (0.7×98.6 mm) with a 10 mm exposed active tip is used. Before performing the ablation, tissue impedance and motor and sensory responses (motor and sensory stimulation) are checked. The expected tissue impedance is <500 ohms. Sensory paresthesia at <1 V and 50 Hz is observed around the sacrococcygeal region. Pulsed RFA is applied at 42 °C for 4 minutes after stimulation.
Conventional RadiofrequencyProcedure or surgery
Once the needle is properly positioned along the sacrococcygeal disc line, 1 mL of radiopaque contrast is injected. The needle placement is confirmed in the lateral fluoroscopic view as a comma-shaped spread in the retroperitoneal space.
Radiofrequency interventions on the ganglion impar are performed using a radiofrequency generator. A 22G radiofrequency needle (0.7×98.6 mm) with a 10 mm exposed active tip is used. Before performing the ablation, tissue impedance and motor and sensory responses (motor and sensory stimulation) are checked. The expected tissue impedance is <500 ohms. Sensory paresthesia at <1 V and 50 Hz is observed around the sacrococcygeal region. Neuroablation is applied for 2 cycles of 90 seconds at 80 °C.
| Study group | Role | What they receive |
|---|---|---|
| Pulse RF Group | Active comparator | Radiofrequency ablation is performed on the ganglion impar using a 22G needle with a 10 mm active tip. Tissue impedance and motor/sensory responses are checked before ablation. Pulsed RFA is applied at 42 °C for 4 minutes.
Pulsed RF treatments will be applied to patients only once, and pain, disability, sleep quality, and patient satisfaction will be assessed before treatment and at 1, 3, 6, and 12 months after the procedure Receives: Procedure: Pulsed Radiofrequency |
| Conventional RF Group | Active comparator | Conventional RF treatments will be applied to patients only once, and pain, disability, sleep quality, and patient satisfaction will be assessed before treatment and at 1, 3, 6, and 12 months after the procedure
Radiofrequency ablation is performed on the ganglion impar using a 22G needle with a 10 mm active tip. Tissue impedance and motor/sensory responses are checked before ablation. Conventional RFA is applied for two cycles of 90 seconds at 80 °C. Receives: Procedure: Conventional Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Rating Scale (NRS)
Pain intensity was assessed using the Numeric Rating Scale (NRS), a linear pain scale ranging from 0 (no pain) to 10 (the worst imaginable pain)."
Measured: From enrollment to the end of treatment at 12th months
Secondary outcomes (3)
Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI): The ODI is a self-reported measure used to assess the extent to which a patient's daily activities are limited. It is one of the most commonly used tools in clinical research and routine patient follow-up to determine the level of functional disability.
General Characteristics: The index consists of 10 sections, each scored from 0 to 5 (0: no difficulty, 5: maximum difficulty). The maximum raw score is 50, and the total score is multiplied by 2 to convert it to a percentage (0-100%).
Assessment Categories (approximate):
0-20%: Minimal disability (the patient can continue daily activities and perform most tasks).
21-40%: Moderate disability.
41-60%: Severe disability (pain significantly affects daily life).
61-80%: Crippling disability (the patient is unable to perform many activities).
81-100%: Bed-bound or completely dependent, unable to maintain an active lifestyle.
Measured: From enrollment to the end of treatment at 12th months
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI): The PSQI includes 18 items that contribute to its scoring. It assesses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Some components are represented by a single item, while others are calculated by grouping several items. Each item is scored from 0 to 3, and the sum of the seven component scores forms the total PSQI score. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total PSQI score of ≤5 indicates "good sleep quality," whereas a score >5 indicates "poor sleep quality."
Measured: From enrollment to the end of treatment at 12 months
Global Perceived Effect (GPE)
Global Perceived Effect (GPE): The GPE measures the patient's perception of their condition compared to a previous period. It reflects the response to the question: "How do you feel now compared to before treatment?" At 1, 3, 6, and 12 months after treatment, the patient's overall perceived effect will be assessed using a 7-point Likert scale:
- - Much worse
- - Worse
- - Slightly worse
- - No change
- - Slightly better
- - Better
- - Much better
Patients reporting "much better" (score = 7) or "better" (score = 6) will be considered satisfied with the procedure.
Measured: From enrollment to the end of treatment at 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients with coccydynia
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Bayram, Adana City Training and Research Hospital
- Investigators
- Derya Bayram, MD, Principal investigator, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497269
- Sponsor's protocol ID
- BAEK-68
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to ensure the confidentiality and privacy of the patients, in accordance with ethical approval and local regulations
Publications
1-Adas, C., Ozdemir, U., Toman, H., Luleci, N., Luleci, E., & Adas, H. (2016). Transsacrococcygeal approach to ganglion impar: radiofrequency application for the treatment of chronic intractable coccydynia. Journal of pain research, 1173-1177. 2-Romanukha, D. M., & Biloshytsky, V. V. (2024). Minimally Invasive Interventions on Ganglion Impar in Treatment of Patients with Coccygodynia. Ukr Neurosurg J, 1, 43-52. 3-Nasiri, A., Vajari, F. F., Sane, S., & Afsargharehbagh, R. (2024). Assessment of ganglion impar block effect on treatment results of coccydynia: a cross-sectional study. Anesthesiology and Pain Medicine, 14(2), e142137. 4-Turchan, A., Fahmi, A., & Subianto, H. (2018). Impar ganglion block with combination of neurolysis drugs and radiofrequency thermocoagulation for perineal pain. Asian Journal of Neurosurgery, 13(03), 838-841. 5-Gupta, M., & Das, G. (2020). Ganglion Impar block and neurolysis for chronic pain: A review. Journal on Musculoskeletal Ultrasound and Pain Medicine, 6(1), 24-28. 6-Usmani H, Dureja GP, Andleeb R, Tauheed N, Asif N. Conventional Radiofrequency Thermocoagulation vs Pulsed Radiofrequency Neuromodulation of Ganglion Impar in Chronic Perineal Pain of Nononcological Origin. Pain Med.2018;19(12):2348-2356. doi:10.1093/pm/pnx244. PMID: 29329442)
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed vs Conventional Radiofrequency of the Ganglion Impar for Coccydynia: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07497269
- Acronym / sponsor ID
- BAEK-68
- Conditions
- Back Pain
- Keywords
- Radiofrequency Ablation, low back pain, quality of life, coccyx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 27 Mar 2026 (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.
The aim of this study is to prospectively evaluate the effects of pulsed and conventional radiofrequency ablation of the ganglion impar on pain, quality of life, and sleep quality in patients with refractory coccydynia, and to determine whether one treatment is superior to the other.
Detailed description
Coccydynia, commonly referred to as tailbone pain, is a persistent pain condition targeting the coccyx, a small triangular bone located at the lower end of the spine. The main cause of this pain is usually abnormal movement in the coccygeal region, which leads to continuous inflammation. Coccydynia more commonly affects women than men and is often associated with obesity. Although it most frequently occurs around the age of 40, it can be seen in individuals of all ages. The origins of coccydynia are varied, including both physical and psychological factors. The main physical causes are trauma from falling onto the buttocks, repetitive minor injuries, or childbirth, which are the most common triggers. Non-traumatic causes of coccydynia include degenerative diseases of the joints or discs, abnormal movements in the sacrococcygeal joint, obesity, infections, changes in the shape of the coccyx, or cancers in the pelvic or anorectal regions. The effectiveness of treatments for coccydynia varies considerably.
Several conservative treatment options exist for coccydynia, such as nonsteroidal anti-inflammatory drugs (NSAIDs), local analgesics, hot or cold applications, transcutaneous electrical nerve stimulation (TENS), specially designed wedge-shaped cushions (coccygeal cushions), and exercises aimed at relaxing the levator ani muscle. These methods aim to reduce pain and inflammation and improve the functionality of the coccyx and surrounding muscles. When these conservative approaches fail to provide relief, more invasive procedures may be considered. Techniques such as direct local anesthetic injections to the coccyx, coccygeal nerve blocks, caudal epidural injections, and ganglion impar blocks offer minimally invasive alternatives for coccydynia treatment. Among the methods for impar ganglion blocks, pulsed RF, thermocoagulation ablation techniques, and neurolytic techniques are considered treatments that provide long-term pain palliation. The transacrococcygeal technique for impar ganglion block is an easy and safe method. This technique allows neurolysis or radiofrequency thermocoagulation ablation of the impar ganglion and can be used for diagnostic blocks depending on the response to initial diagnostic injections.
The ganglion impar (Walther ganglion) is a single sympathetic ganglion formed by the convergence of the distal ends of the lumbosacral sympathetic chains. It is the lowest ganglion of the sympathetic nervous system. Being single and medial (unlike the paired paravertebral sympathetic ganglia), it is the only solitary sympathetic ganglion. It is located retroperitoneally, anterior to the sacrum, at the level of the sacrococcygeal symphysis, and posterior to the rectum. It provides sympathetic efferent fibers and receives afferent sensory information from many pelvic structures, supplying sympathetic and nociceptive innervation to the perineum, coccyx, anus, distal rectum, vulva, urethra, and vagina. Interventions on the ganglion impar disrupt afferent sympathetic and nociceptive pathways from the pelvis, perineum, and anal region. Interventions on the ganglion impar can be performed using various agents and techniques, including local anesthetics, corticosteroids, ethanol, phenol, botulinum toxin, radiofrequency ablation (RFA) or modulation (RFM), and cryoablation. The transsacrococcygeal technique is more commonly used. Numerous technique variations exist, but the goal is to successfully direct the needle to the anterior surface of the coccyx or sacrococcygeal symphysis to deliver local anesthetics, steroids, or neurolytic agents without damaging pelvic bones or organs. Radiopaque contrast is injected to visualize proper retroperitoneal distribution of the agent along the anterior surface of the coccyx.
Visceral pain mediated by sympathetic fibers in the perineal region can be effectively treated by neurolysis of the impar ganglion. Theoretically, this procedure can also be applied for pain due to malignancy, endometriosis, complex regional pain syndrome, prostate pain, radiation-induced enteritis, postherpetic neuralgia, and refractory coccydynia. The use of sympathetic chain ablation for persistent pain in the sacral-pelvic region differs from other targets, because the anatomical variation of the impar ganglion requires careful combination of radiofrequency thermocoagulation and neurolytic agents (alcohol or phenol) to maximize pain control. When using the thermocoagulation radiofrequency ablation technique, special equipment such as electrostimulation devices and minute controllers are required. Therefore, selective destruction of nerve fibers is possible, and the size and location of the lesion can be controlled, resulting in a lower risk of complications.
The effects of conventional radiofrequency (CRF) thermocoagulation for chronic coccydynia were retrospectively analyzed (patients unresponsive to conservative treatment and local injections for 6 months. Ten patients who responded to diagnostic block with 10 mL of 0.25% bupivacaine underwent CRF treatment. Approximately 90% of patients achieved successful results at 6 months, defined as a 50% reduction in VAS scores. Transcoccygeal/intercoccygeal CRF of the ganglion impar is simple, relatively safe, and should be considered for chronic coccydynia unresponsive to conservative therapy for 6 months. Similar findings were observed by another study in a retrospective analysis of CRF in 20 patients with chronic refractory coccydynia.
No previous study has compared the superiority of these two routinely applied long-term coccyx pain treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of patients with coccydynia
| Arm | Type | Receives |
|---|---|---|
| Pulse RF Group | Active comparator | Procedure: Pulsed RadiofrequencyRadiofrequency ablation is performed on the ganglion impar using a 22G needle with a 10 mm active tip. Tissue impedance and motor/sensory responses are checked before ablation. Pulsed RFA is applied at 42 °C for 4 minutes. Pulsed RF treatments will be applied to patients only once, and pain, disability, sleep quality, and patient satisfaction will be assessed before treatment and at 1, 3, 6, and 12 months after the procedure |
| Conventional RF Group | Active comparator | Procedure: Conventional RadiofrequencyConventional RF treatments will be applied to patients only once, and pain, disability, sleep quality, and patient satisfaction will be assessed before treatment and at 1, 3, 6, and 12 months after the procedure Radiofrequency ablation is performed on the ganglion impar using a 22G needle with a 10 mm active tip. Tissue impedance and motor/sensory responses are checked before ablation. Conventional RFA is applied for two cycles of 90 seconds at 80 °C. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years.
- Chronic pain in the coccygeal region lasting longer than 3 months, unresponsive to analgesics, anti-inflammatory drugs, and other conservative treatment methods.
- Patients scheduled to undergo ganglion impar treatment with either conventional or pulsed radiofrequency ablation (RFA).
Key exclusion criteria (9 listed)
- Incomplete medical records.
- Loss to follow-up.
- Technical failure during the block procedure.
- Local infection, bleeding disorders, allergy to contrast agents, or history of spinal surgery.
- History of 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 |
|---|---|---|
| Pulsed RadiofrequencyOnce the needle is properly positioned along the sacrococcygeal disc line, 1 mL of radiopaque contrast is injected. The needle placement is confirmed in the lateral fluoroscopic view as a comma-shaped spread in the retroperitoneal space. Radiofrequency interventions on the ganglion impar are performed using a radiofrequency generator. A 22G radiofrequency needle (0.7×98.6 mm) with a 10 mm exposed active tip is used. Before performing the ablation, tissue impedance and motor and sensory responses (motor and sensory stimulation) are checked. The expected tissue impedance is <500 ohms. Sensory paresthesia at <1 V and 50 Hz is observed around the sacrococcygeal region. Pulsed RFA is applied at 42 °C for 4 minutes after stimulation. | Procedure or surgery | Pulse RF Group |
| Conventional RadiofrequencyOnce the needle is properly positioned along the sacrococcygeal disc line, 1 mL of radiopaque contrast is injected. The needle placement is confirmed in the lateral fluoroscopic view as a comma-shaped spread in the retroperitoneal space. Radiofrequency interventions on the ganglion impar are performed using a radiofrequency generator. A 22G radiofrequency needle (0.7×98.6 mm) with a 10 mm exposed active tip is used. Before performing the ablation, tissue impedance and motor and sensory responses (motor and sensory stimulation) are checked. The expected tissue impedance is <500 ohms. Sensory paresthesia at <1 V and 50 Hz is observed around the sacrococcygeal region. Neuroablation is applied for 2 cycles of 90 seconds at 80 °C. | Procedure or surgery | Conventional RF Group |
Primary outcome
The Numeric Rating Scale (NRS)
Time frame: From enrollment to the end of treatment at 12th months
Pain intensity was assessed using the Numeric Rating Scale (NRS), a linear pain scale ranging from 0 (no pain) to 10 (the worst imaginable pain)."
3 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: From enrollment to the end of treatment at 12th months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: From enrollment to the end of treatment at 12 months
Global Perceived Effect (GPE)
Time frame: From enrollment to the end of treatment at 12th months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background1-Adas, C., Ozdemir, U., Toman, H., Luleci, N., Luleci, E., & Adas, H. (2016). Transsacrococcygeal approach to ganglion impar: radiofrequency application for the treatment of chronic intractable coccydynia. Journal of pain research, 1173-1177. 2-Romanukha, D. M., & Biloshytsky, V. V. (2024). Minimally Invasive Interventions on Ganglion Impar in Treatment of Patients with Coccygodynia. Ukr Neurosurg J, 1, 43-52. 3-Nasiri, A., Vajari, F. F., Sane, S., & Afsargharehbagh, R. (2024). Assessment of ganglion impar block effect on treatment results of coccydynia: a cross-sectional study. Anesthesiology and Pain Medicine, 14(2), e142137. 4-Turchan, A., Fahmi, A., & Subianto, H. (2018). Impar ganglion block with combination of neurolysis drugs and radiofrequency thermocoagulation for perineal pain. Asian Journal of Neurosurgery, 13(03), 838-841. 5-Gupta, M., & Das, G. (2020). Ganglion Impar block and neurolysis for chronic pain: A review. Journal on Musculoskeletal Ultrasound and Pain Medicine, 6(1), 24-28. 6-Usmani H, Dureja GP, Andleeb R, Tauheed N, Asif N. Conventional Radiofrequency Thermocoagulation vs Pulsed Radiofrequency Neuromodulation of Ganglion Impar in Chronic Perineal Pain of Nononcological Origin. Pain Med.2018;19(12):2348-2356. doi:10.1093/pm/pnx244. PMID: 29329442)
- Individual participant dataSharing planned: No. Individual participant data will not be shared to ensure the confidentiality and privacy of the patients, in accordance with ethical approval and local regulations
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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.
Derya Bayram, MD principal investigator
Adana City Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency and Conventional Radiofrequency in people with Back Pain, run by Adana City Training and Research Hospital at 2 sites 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derya Bayram, MD (+905433400430, deryak.bayram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Rating Scale (NRS) (time frame: From enrollment to the end of treatment at 12th months). 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 NCT07497269, 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 28 Oct 2026.