Pain ManagementNCT07247565
Comparative Study Between Conventional Radiofrequency Ablation vs Chemical Neurolysis of Ganglion Impar for Treatment of Chronic Non Cancer Related Coccydynia
A study testing Radiofrequency ablation alone and Alcohol injection in people with Pain Management, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim: compare effectiveness (satisfaction) and duration of pain relief between patients who perform the conventional thermal radiofrequency on the ganglion impar vs patients who perform the chemical neurolysis with alcohol in patients with non cancer coccydynia patients with non cancer coccydynia not responding to… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Radiofrequency ablation alone and Alcohol injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to Dec 2025
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non cancer coccydynia
- Both genders
- Age between 20-70 years.
- ASA 1,2 \& 3 physical status
- xray coccyx lateral position showing normal joints and bones with no fractures
Who cannot join
- Neurological disorders. (previous central and peripheral CNS affection).
- coagulopathy INR > 1.8 or platelets < 50,000.
- Infection at or near the injection site.
- Presence of pacemaker or defibrillator.
- known allergy to used medications.
- patients with previous history of Radiotherapy, chemotherapy or metastasis
Show all 10Show fewer
- pregnant patients.
- patients with rheumatological disorders (rheumatoid arthritis, diffuse idiopathic skeletal hyerostosis, psoriatic arthritis)
- age <20 or >70
- Xray coccyx showing fractures or abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Aim: compare effectiveness (satisfaction) and duration of pain relief between patients who perform the conventional thermal radiofrequency on the ganglion impar vs patients who perform the chemical neurolysis with alcohol in patients with non cancer coccydynia patients with non cancer coccydynia not responding to medical treatment will be divided into 2 groups before intervention , control group will receive conventional radiofrequency ablation of ganglion impar , while the study group will receive alcohol neurolysis
- Conditions
- Pain Management
- Being tested
- Radiofrequency ablation alone, Alcohol injection
- Keywords
- coccydinea, pain, radiofrequency, alcohol neurolysis
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
The entry site was detected under fluoroscopy then local anesthesia was given using lidocaine 2% followed by the insertion of a radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the junction between the coccygeal bones and pass through it anteriorly in the lateral view. Finally confirming the proper site with a contrast dye in lateral and A-P views.
10 ml of lidocaine 1 % was injected to tolerate the ablation then in the 1st group placing of the radiofrequency cable followed by ablation will be done at 80 degrees for 90 seconds.
Alcohol injectionProcedure or surgery
The entry site was detected under fluoroscopy then local anesthesia was given using lidocaine 2% followed by the insertion 22 G spinal needle targeting the junction between the coccygeal bones and pass through it anteriorly in the lateral view. Finally confirming the proper site with a contrast dye in lateral and A-P views.
10 ml of lidocaine 1 % was injected to tolerate the ablation then injection of 5 ml 70% alcohol will be performed
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency group | Active comparator | patients with non cancer coccydynia in this group will receive conventional radiofrequency on ganglion impar Receives: Procedure: Radiofrequency ablation alone |
| alcohol neurolysis group | Experimental | patients in this group will receive alcohol neurolysis on ganglion impar Receives: Procedure: Alcohol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief using Numeric Pain score scale
patients will be asked to describe their pain on Numeric pain scale ( an 11 numbers scale where 0 describes no pain and 10 describes the worst pain ) and compare it to before the procedure
Measured: 1 month
pain relief of chronic non cancer coccydynia
patients will be asked to describe their pain on Numeric pain scale and compare it to before the procedure
Measured: 6 months after the procedure
patient global impression of change (PGIC)
one-item questionnaire that asks patients to rate their overall improvement after a treatment.he scale typically includes ratings such as "very much improved," "much improved," "minimally improved," "unchanged," or "worse".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Mar 2025
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (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 Pain ManagementStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia edward aziz zakhary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247565
- Sponsor's protocol ID
- non cancer coccydynia
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fogel GR, Cunningham PY 3rd, Esses SI. Coccygodynia: evaluation and management. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):49-54. doi: 10.5435/00124635-200401000-00007.
PubMed 14753797
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Conventional Radiofrequency Ablation vs Chemical Neurolysis of Ganglion Impar for Treatment of Chronic Non Cancer Related Coccydynia
- ClinicalTrials.gov ID
- NCT07247565
- Acronym / sponsor ID
- non cancer coccydynia
- Conditions
- Pain Management
- Keywords
- coccydinea, pain, radiofrequency, alcohol neurolysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Nov 2025 (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.
Aim: compare effectiveness (satisfaction) and duration of pain relief between patients who perform the conventional thermal radiofrequency on the ganglion impar vs patients who perform the chemical neurolysis with alcohol in patients with non cancer coccydynia patients with non cancer coccydynia not responding to medical treatment will be divided into 2 groups before intervention , control group will receive conventional radiofrequency ablation of ganglion impar , while the study group will receive alcohol neurolysis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency group | Active comparator | Procedure: Radiofrequency ablation alonepatients with non cancer coccydynia in this group will receive conventional radiofrequency on ganglion impar |
| alcohol neurolysis group | Experimental | Procedure: Alcohol injectionpatients in this group will receive alcohol neurolysis on ganglion impar |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- non cancer coccydynia
Key exclusion criteria (10 listed)
- Neurological disorders. (previous central and peripheral CNS affection).
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 |
|---|---|---|
| Radiofrequency ablation aloneThe entry site was detected under fluoroscopy then local anesthesia was given using lidocaine 2% followed by the insertion of a radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the junction between the coccygeal bones and pass through it anteriorly in the lateral view. Finally confirming the proper site with a contrast dye in lateral and A-P views. 10 ml of lidocaine 1 % was injected to tolerate the ablation then in the 1st group placing of the radiofrequency cable followed by ablation will be done at 80 degrees for 90 seconds. | Procedure or surgery | radiofrequency group |
| Alcohol injectionThe entry site was detected under fluoroscopy then local anesthesia was given using lidocaine 2% followed by the insertion 22 G spinal needle targeting the junction between the coccygeal bones and pass through it anteriorly in the lateral view. Finally confirming the proper site with a contrast dye in lateral and A-P views. 10 ml of lidocaine 1 % was injected to tolerate the ablation then injection of 5 ml 70% alcohol will be performed | Procedure or surgery | alcohol neurolysis group |
Primary outcome
pain relief using Numeric Pain score scale
Time frame: 1 month
patients will be asked to describe their pain on Numeric pain scale ( an 11 numbers scale where 0 describes no pain and 10 describes the worst pain ) and compare it to before the procedure
pain relief of chronic non cancer coccydynia
Time frame: 6 months after the procedure
patients will be asked to describe their pain on Numeric pain scale and compare it to before the procedure
patient global impression of change (PGIC)
Time frame: 6 months
one-item questionnaire that asks patients to rate their overall improvement after a treatment.he scale typically includes ratings such as "very much improved," "much improved," "minimally improved," "unchanged," or "worse".
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 25 Nov 2025.
- Background: PubMed 14753797Fogel GR, Cunningham PY 3rd, Esses SI. Coccygodynia: evaluation and management. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):49-54. doi: 10.5435/00124635-200401000-00007.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone and Alcohol injection in people with Pain Management, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. 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 Egypt. 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?
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?
pain relief using Numeric Pain score scale (time frame: 1 month). The study lists 3 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 NCT07247565, 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 25 Nov 2025.