Chronic PainNCT03884764
Ganglion Impar Denervation and Radiofrequency on Sacral Root 3 for Chronic Prostatic Pain
A study testing pulsed radiofrequency and ganglion impar denervation in people with Chronic Pain, run by Assiut University at 1 site in Egypt.
Trial summary
the authors will evaluate the added analgesic benefit of pulsed radiofrequency on sacral root 3 with ganglion impar denervation on chronic pelvic pain due to chronic prostatitis Read more about this study
- Who is it for?
- Ages 16 to 80 years, men only
- Conditions the study is for
- Chronic Pain
- What is being tested?
- pulsed radiofrequency and ganglion impar denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 15 Dec 2020
- 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 16 to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with chronic pelvic pain due to chronic prostatitis for at least 3 months
- VAS pain score more than 5
- failed analgesic drug treatment
Who cannot join
- coagulopathy
- neurogenic bladder
- infection at site of procedure
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Diab
Asyut, Assuit, 71515
Diab Hetta, MD, +201091090009, diabgetta25@gmail.com
About this study
Official title: for Patients With Chronic Pelvic Pain Due to Chronic Prostatitis, do Combined Ganglion Impar Denervation and Pulsed Radiofrequency on Sacral Root 3 Acheive Better Analgesia Than Ganglion Impar Alone
the authors will evaluate the added analgesic benefit of pulsed radiofrequency on sacral root 3 with ganglion impar denervation on chronic pelvic pain due to chronic prostatitis
- Conditions
- Chronic Pain
- Being tested
- pulsed radiofrequency, ganglion impar denervation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed radiofrequencyProcedure or surgery
patients with chronic pelvic pain due to chronic prostatitis will receive pulsed radiofrequency on sacral root number 3 and ganglion impar denervation and the patients will be followed for 6 months to assess pain severity radiofrequency procedure: patients will positioned prone on the operating table and under x-ray guidence sacral foramen number 3 will be identified and through it radiofrequency needle will be advanced to target the sacral root ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected
ganglion impar denervationProcedure or surgery
patients with chronic pelvic pain due to chronic prostatitis will receive ganglion impar denervationand and the patients will be followed for 6 months to assess pain severity ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected
| Study group | Role | What they receive |
|---|---|---|
| PRF on S3 + ganglion impar denervation | Experimental | patients will receive pulsed radiofrequency on sacral root number 3 in conjunction with ganglion impar denervation by alcohol Receives: Procedure: pulsed radiofrequency |
| ganglion impar denervation | Active comparator | patients will receive ganglion impar denervation by alcohol Receives: Procedure: ganglion impar denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score
VAS pain is a scale of pain measurements scored grom 0 to 10 in which 0 = no pain and 10 the worst pain immaginable
Measured: patients will be evaluated at 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diab Fuad Hetta, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884764
- Sponsor's protocol ID
- SECI-IRB-IORG0009563-724
- Status last verified
- Sep 2020
- First submitted
- 20 Mar 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- for Patients With Chronic Pelvic Pain Due to Chronic Prostatitis, do Combined Ganglion Impar Denervation and Pulsed Radiofrequency on Sacral Root 3 Acheive Better Analgesia Than Ganglion Impar Alone
- ClinicalTrials.gov ID
- NCT03884764
- Acronym / sponsor ID
- SECI-IRB-IORG0009563-724
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 21 Mar 2019 (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 authors will evaluate the added analgesic benefit of pulsed radiofrequency on sacral root 3 with ganglion impar denervation on chronic pelvic pain due to chronic prostatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF on S3 + ganglion impar denervation | Experimental | Procedure: pulsed radiofrequencypatients will receive pulsed radiofrequency on sacral root number 3 in conjunction with ganglion impar denervation by alcohol |
| ganglion impar denervation | Active comparator | Procedure: ganglion impar denervationpatients will receive ganglion impar denervation by alcohol |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with chronic pelvic pain due to chronic prostatitis for at least 3 months
- VAS pain score more than 5
- failed analgesic drug treatment
Key exclusion criteria (3 listed)
- coagulopathy
- neurogenic bladder
- infection at site of procedure
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 radiofrequencypatients with chronic pelvic pain due to chronic prostatitis will receive pulsed radiofrequency on sacral root number 3 and ganglion impar denervation and the patients will be followed for 6 months to assess pain severity radiofrequency procedure: patients will positioned prone on the operating table and under x-ray guidence sacral foramen number 3 will be identified and through it radiofrequency needle will be advanced to target the sacral root ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected | Procedure or surgery | PRF on S3 + ganglion impar denervation |
| ganglion impar denervationpatients with chronic pelvic pain due to chronic prostatitis will receive ganglion impar denervationand and the patients will be followed for 6 months to assess pain severity ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected | Procedure or surgery | ganglion impar denervation |
Primary outcome
the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score
Time frame: patients will be evaluated at 3 months postoperatively
VAS pain is a scale of pain measurements scored grom 0 to 10 in which 0 = no pain and 10 the worst pain immaginable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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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.
1 site 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 ganglion impar denervation in people with Chronic Pain, run by Assiut 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 3 inclusion and 3 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 16 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score (time frame: patients will be evaluated at 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2020.