Neuropathy;PeripheralNCT05480527
Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy
A study testing Transcutaneous pulsed radiofrequency current in people with Neuropathy;Peripheral, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators want to investigate the efficacy of transcutaneous pulsed radiofrequency therapy in the treatment of diabetic peripheral neuropathy symptoms. For this purpose, investigators aimed to compare the results of two groups treated with sham electrode and active electrode. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathy;Peripheral
- What is being tested?
- Transcutaneous pulsed radiofrequency current
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Dec 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
- Clinical diagnosis of Diabetes Mellitus
- Peripheric neuropathy with proved electroneuromyography
Who cannot join
- Additional endocrinological disease,
- Pregnancy, malignancy, motor deficit in lower extremities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dişkapi Reserch and Education Hospital
Ankara
damla S YURUK, 5319932378 ext. 5319932378, damlayuruk@hotmail.com
Ömer Taylan S Akkaya, 5067152323 ext. 5319932378, dr.taylanakkaya@gmail.com
About this study
Official title: Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain
Investigators want to investigate the efficacy of transcutaneous pulsed radiofrequency therapy in the treatment of diabetic peripheral neuropathy symptoms. For this purpose, investigators aimed to compare the results of two groups treated with sham electrode and active electrode.
Read the detailed description
Peripheral neuropathic pain is common in diabetes mellitus. Distal symmetrical polyneuropathy is the most common form. These patients have complaints such as burning, freezing, tingling and pain in their hands and feet. Peripheral nerve blocks or sympathetic blocks are applied to patients who cannot be treated with medical agents.
Transcutaneous pulsed radiofrequency is a method used in the treatment of pain. The advantages of transcutaneous pulsed radiofrequency method are that it is not invasive, does not cause side effects, and does not interact with drugs. We want to investigate the efficacy of diabetic peripheral neuropathic pain treatment with this method.
Sixty diabetic polyneuropathy patients will be included in the study. Transcutaneous pulsed radiofrequency therapy with active electrode will be applied to half of the patients. Sham electrode will be used for the other half. Patients will not know which group they belong to. Two treatments will be applied with 7 days intervals. The duration of treatment will be 8 minutes.Each patient will receive a Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS). Before the treatment, in the first month and third month after the treatment, the patients will be filled with a visual analog scale. The results between both groups will be statistically compared.
- Conditions
- Neuropathy;Peripheral
- Being tested
- Transcutaneous pulsed radiofrequency current
- Keywords
- neuropathic pain, transcutaneous pulsed radiofrequency
- Medical subject headings
- Neuritis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous pulsed radiofrequency currentDevice
Active treating group: 80 volts, 2Hz, 20 ms pulsed radiofrequency current will be applied to the tibial nerve trace in the ankle with electrodes. Sham group: Elelctrodes will be attached but radiofrequency current will not be applied.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bilateral neuropathic pain which treating active electrode | Active comparator | 30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. Receives: Device: Transcutaneous pulsed radiofrequency current |
| Patients with bilateral neuropathic pain which applied sham electrode | Sham comparator | Sham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. Receives: Device: Transcutaneous pulsed radiofrequency current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12
The visual analogue scale (VAS) is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain).
Measured: Bseline, week 4 and week 12
Secondary outcomes (1)
Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
it is a 7-item self-report scale developed to identify pain of predominantly neuropathic origin. Scores range 0 and 24. Scores of 12 and above are associated with neuropathic pain
Measured: baseline, week4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Dec 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy;PeripheralStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Mehlika Panpallı Ateş, Study chair, Diskapi Yildirim Beyazit Education and Research HospitalDamla Yürük, Study chair, Diskapi Yildirim Beyazit Education and Research HospitalÖmer Taylan Akkaya, Study director, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480527
- Sponsor's protocol ID
- Diabetic PNP
- Status last verified
- Feb 2023
- First submitted
- 27 Jul 2022
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain
- ClinicalTrials.gov ID
- NCT05480527
- Acronym / sponsor ID
- Diabetic PNP
- Conditions
- Neuropathy;Peripheral
- Keywords
- neuropathic pain, transcutaneous pulsed radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 29 Jul 2022 (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.
Investigators want to investigate the efficacy of transcutaneous pulsed radiofrequency therapy in the treatment of diabetic peripheral neuropathy symptoms. For this purpose, investigators aimed to compare the results of two groups treated with sham electrode and active electrode.
Detailed description
Peripheral neuropathic pain is common in diabetes mellitus. Distal symmetrical polyneuropathy is the most common form. These patients have complaints such as burning, freezing, tingling and pain in their hands and feet. Peripheral nerve blocks or sympathetic blocks are applied to patients who cannot be treated with medical agents.
Transcutaneous pulsed radiofrequency is a method used in the treatment of pain. The advantages of transcutaneous pulsed radiofrequency method are that it is not invasive, does not cause side effects, and does not interact with drugs. We want to investigate the efficacy of diabetic peripheral neuropathic pain treatment with this method.
Sixty diabetic polyneuropathy patients will be included in the study. Transcutaneous pulsed radiofrequency therapy with active electrode will be applied to half of the patients. Sham electrode will be used for the other half. Patients will not know which group they belong to. Two treatments will be applied with 7 days intervals. The duration of treatment will be 8 minutes.Each patient will receive a Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS). Before the treatment, in the first month and third month after the treatment, the patients will be filled with a visual analog scale. The results between both groups will be statistically compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with bilateral neuropathic pain which treating active electrode | Active comparator | Device: Transcutaneous pulsed radiofrequency current30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. |
| Patients with bilateral neuropathic pain which applied sham electrode | Sham comparator | Device: Transcutaneous pulsed radiofrequency currentSham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Diabetes Mellitus
- Peripheric neuropathy with proved electroneuromyography
Key exclusion criteria (2 listed)
- Additional endocrinological disease,
- Pregnancy, malignancy, motor deficit in lower extremities
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 |
|---|---|---|
| Transcutaneous pulsed radiofrequency currentActive treating group: 80 volts, 2Hz, 20 ms pulsed radiofrequency current will be applied to the tibial nerve trace in the ankle with electrodes. Sham group: Elelctrodes will be attached but radiofrequency current will not be applied. | Device | Patients with bilateral neuropathic pain which applied sham electrode, Patients with bilateral neuropathic pain which treating active electrode |
Primary outcome
Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12
Time frame: Bseline, week 4 and week 12
The visual analogue scale (VAS) is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain).
1 secondary outcome
Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Time frame: baseline, week4 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Mehlika Panpallı Ateş study chair
Diskapi Yildirim Beyazit Education and Research Hospital
Damla Yürük study chair
Diskapi Yildirim Beyazit Education and Research Hospital
Ömer Taylan Akkaya study director
Diskapi Yildirim Beyazit Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous pulsed radiofrequency current in people with Neuropathy;Peripheral, run by Diskapi Teaching and Research Hospital at 1 site 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 2 inclusion and 2 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 May 2023. 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 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. Some participants in this study may receive a placebo. 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?
Contact Gevher Rabia Genc Perdecioglu (05332009184, gevhergenc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12 (time frame: Bseline, week 4 and week 12). 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 May 2023.