Transcutaneous Pulsed Radiofrequency in Diabetic Polyneuropathy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 16, 2023
February 1, 2023
1.9 years
July 27, 2022
May 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Bseline, week 4 and week 12
Secondary Outcomes (1)
Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
baseline, week4 and week 12
Study Arms (2)
Patients with bilateral neuropathic pain which treating active electrode
ACTIVE COMPARATOR30 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 COMPARATORSham electrodes will be applied to 30 patients. All patients have diabetic polyneuropathy and confirmed with electroneuromyography.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Diabetes Mellitus
- Peripheric neuropathy with proved electroneuromyography
You may not qualify if:
- Additional endocrinological disease,
- Pregnancy, malignancy, motor deficit in lower extremities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dişkapi Reserch and Education Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, medical doctor
Study Record Dates
First Submitted
July 27, 2022
First Posted
July 29, 2022
Study Start
December 1, 2021
Primary Completion
November 1, 2023
Study Completion
December 1, 2023
Last Updated
May 16, 2023
Record last verified: 2023-02