Pain, ChronicNCT05024682
Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia
A study testing conventional pulsed radiofrequency and pulse dosed pulsed radiofrequency in people with Pain, Chronic, run by Assiut University at 1 site in Egypt.
Trial summary
The relatively complex anatomical structure of the pelvis has been a focus of study in the medical field. The diagnosis of the causes of chronic pelvic pain is usually a complicated process. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- conventional pulsed radiofrequency and pulse dosed pulsed radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2022to 3 Feb 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain located in the pudendal nerve distribution area
- pain intensity increases in the sitting position;
- no nocturnal pain symptoms;
- pain with no objective sensory impairment
- pain is relieved by diagnostic pudendal
- the pain symptom is associated with sexual dysfunction, with the elimination of obstetrical and gynaecologic, urological and anorectal diseases in the related departments and absence of any physical and mental disorders;
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- treatment by other departments is invalid;
- patients should be older than 18 years
- patients should be able to sign an informed consent form
Who cannot join
- patients have simple tailbone, gluteus muscle or lower abdominal pain, or only paroxysmal pain, or only pruritic symptoms, and/or have imaging anomalies that may explain the symptoms;
- female patients who are pregnant;
- patients who take anticoagulant drugs or have any coagulation disorder;
- patients who are unable to complete the questionnaire;
- patients with pain, which is caused by malignant or autoimmune diseases and
- patients who are hypersensitive to metals.
Trial locations and contacts
1 site in 1 country.
About this study
The relatively complex anatomical structure of the pelvis has been a focus of study in the medical field. The diagnosis of the causes of chronic pelvic pain is usually a complicated process.
Pudendal neuralgia is a syndrome that is characterized by pelvic pain, including bowel, bladder regional pain or discomfort, sexual dysfunction, severe burning sensations and needle-like pain, which are aggravated when seated and relieved after standing. pudendal neuralgias are induced by pudendal nerve damage The mechanism of PRF has been studied repeatedly. It has been verified that PRF has definite safe treatment range, but during the PRF treatment, the tissue surrounding the electrode may have some degree of change and so it is difficult to assess any actual damage.7 Based on electric field intensity, PRF can actually produce tissue changes observable as in vitro changes to ultrastructure in early-phase histologic study. These biological changes were converted to biological effect to alleviate neuropathic pain in animal models.
- Conditions
- Pain, Chronic
- Being tested
- conventional pulsed radiofrequency, pulse dosed pulsed radiofrequency
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional pulsed radiofrequencyDevice
After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 120 seconds pulse mode which consisted of four cycles (8 minutes)
pulse dosed pulsed radiofrequencyDevice
After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 240 seconds pulse dose mode which consisted of two cycles (8 minutes).
| Study group | Role | What they receive |
|---|---|---|
| conventional pulsed radiofrequency | Experimental | Not described Receives: Device: conventional pulsed radiofrequency |
| pulse dosed pulsed radiofrequency | Experimental | Not described Receives: Device: pulse dosed pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score
The VAS score was used that has 0-10 points. The 0 point represents the painless state and a score from 1 to 3 points represents mild pain, from 4 to 6 points represents moderate pain and from 7 to 10 points represents severe pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start3 Jan 2022 (estimated)
- Primary completion3 Jan 2023 (estimated)
- Study completion3 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeid Metwaly Abouelyazid Elsawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024682
- Sponsor's protocol ID
- wx1569
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia
- ClinicalTrials.gov ID
- NCT05024682
- Acronym / sponsor ID
- wx1569
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (estimated)
- Primary completion
- 3 Jan 2023 (estimated)
- Study completion
- 3 Feb 2023 (estimated)
- First posted
- 27 Aug 2021 (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 relatively complex anatomical structure of the pelvis has been a focus of study in the medical field. The diagnosis of the causes of chronic pelvic pain is usually a complicated process.
Pudendal neuralgia is a syndrome that is characterized by pelvic pain, including bowel, bladder regional pain or discomfort, sexual dysfunction, severe burning sensations and needle-like pain, which are aggravated when seated and relieved after standing. pudendal neuralgias are induced by pudendal nerve damage The mechanism of PRF has been studied repeatedly. It has been verified that PRF has definite safe treatment range, but during the PRF treatment, the tissue surrounding the electrode may have some degree of change and so it is difficult to assess any actual damage.7 Based on electric field intensity, PRF can actually produce tissue changes observable as in vitro changes to ultrastructure in early-phase histologic study. These biological changes were converted to biological effect to alleviate neuropathic pain in animal models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional pulsed radiofrequency | Experimental | Device: conventional pulsed radiofrequency |
| pulse dosed pulsed radiofrequency | Experimental | Device: pulse dosed pulsed radiofrequency |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- pain located in the pudendal nerve distribution area
- pain intensity increases in the sitting position;
- no nocturnal pain symptoms;
- pain with no objective sensory impairment
- pain is relieved by diagnostic pudendal
Key exclusion criteria (6 listed)
- patients have simple tailbone, gluteus muscle or lower abdominal pain, or only paroxysmal pain, or only pruritic symptoms, and/or have imaging anomalies that may explain the symptoms;
- female patients who are pregnant;
- patients who take anticoagulant drugs or have any coagulation disorder;
- patients who are unable to complete the questionnaire;
- patients with pain, which is caused by malignant or autoimmune diseases and
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 |
|---|---|---|
| conventional pulsed radiofrequencyAfter connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 120 seconds pulse mode which consisted of four cycles (8 minutes) | Device | conventional pulsed radiofrequency |
| pulse dosed pulsed radiofrequencyAfter connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 240 seconds pulse dose mode which consisted of two cycles (8 minutes). | Device | pulse dosed pulsed radiofrequency |
Primary outcome
visual analogue score
Time frame: 3 months
The VAS score was used that has 0-10 points. The 0 point represents the painless state and a score from 1 to 3 points represents mild pain, from 4 to 6 points represents moderate pain and from 7 to 10 points represents severe pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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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 conventional pulsed radiofrequency and pulse dosed pulsed radiofrequency in people with Pain, Chronic, 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 9 inclusion and 6 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 27 Aug 2021. 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?
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?
visual analogue score (time frame: 3 months). 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 27 Aug 2021.