Conventional vs Pulsed RF in Coccydynia
ConditionBack Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAdana City Training and Research Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulsed Radiofrequency
Procedure/SurgeryOnce 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 Radiofrequency
Procedure/SurgeryOnce 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Pulse RF GroupActive comparator 1 intervention
Group B: Conventional RF GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)."
Time frame
From enrollment to the end of treatment at 12th monthsSecondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 12th months2
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."
Time frame
From enrollment to the end of treatment at 12 months3
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: 1. \- Much worse 2. \- Worse 3. \- Slightly worse 4. \- No change 5. \- Slightly better 6. \- Better 7. \- Much better Patients reporting "much better" (score = 7) or "better" (score = 6) will be considered satisfied with the procedure.
Time frame
From enrollment to the end of treatment at 12th monthsSponsors and contacts
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Source ClinicalTrials.gov
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