Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05480527
Status:
RECRUITING
Last Update Posted:
2023-05-16
First Post:
2022-07-27
Brief Title:
Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy
Sponsor:
Diskapi Teaching and Research Hospital
Organization:
Diskapi Teaching and Research Hospital
Study Overview
Official Title:
Transcutaneous Pulsed Radiofrequency in Diabetic Neurophatic Pain
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 minutesEach 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
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 minutesEach 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None