Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Patients with bilateral neuropathic pain which treating active electrode 30 patients which treating with transcutaneous pulsed radiofrequency. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. |
Device: Transcutaneous pulsed radiofrequency current
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.
|
| Sham Comparator: Patients with bilateral neuropathic pain which applied sham electrode Sham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography. |
Device: Transcutaneous pulsed radiofrequency current
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.
|
Outcome Measures
Primary Outcome Measures
- Change from baselina in pain on the Visual Analog Scale (VAS) at week 4 and 12 [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).
Secondary Outcome Measures
- Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) [baseline, week4 and week 12]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinical diagnosis of Diabetes Mellitus
-
Peripheric neuropathy with proved electroneuromyography
Exclusion Criteria:
-
Additional endocrinological disease,
-
Pregnancy, malignancy, motor deficit in lower extremities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dişkapi Reserch and Education Hospital | Ankara | Turkey |
Sponsors and Collaborators
- Diskapi Teaching and Research Hospital
Investigators
- Study Chair: Mehlika Panpallı Ateş, Diskapi Yildirim Beyazit Education and Research Hospital
- Study Chair: Damla Yürük, Diskapi Yildirim Beyazit Education and Research Hospital
- Study Director: Ömer Taylan Akkaya, Diskapi Yildirim Beyazit Education and Research Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Diabetic PNP