Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain

Diabetic Neuropathy, Painful Clinical Trial

Official title:

Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05917249
• Other study ID #: Ms-399-2022
• Status: Completed
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease in foot sensation. Therefore, the treatment of this disorder is very important.

Description:

The current study aimed to investigate the efficacy of TECAR therapy on lower limb perfusion index (PI) and to evaluate the efficacy of TECAR therapy in improving the peripheral vascularity, reducing foot pain, and improving the tactile sensation of the soles in diabetic peripheral neuropathy (DPN) patients. twenty three diabetic neuropathy patients were included in the study and underwent 12 sessions of Capacitive TECAR therapy over one month. Pain, tactile sensation of the sole and PI were evaluated at the start and after each session till the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 30, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 40-70 years
• Type II DM with DPN (grade I-II) in lower limbs
• Duration of DM>5 years
• Visual Analog Scale (VAS) =3 in the feet
• Sensory impairments in the lower extremities

Exclusion Criteria:

• Patient with previous stenting or surgical intervention of lower limb arterial system.
• Patients with previous history of DVT.
• Pregnancy
• Diabetic infectious wound
• Cardiac pacemaker presence
• Severe liver and kidney dysfunction or history of heart and lung disease.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Neuralgia

Intervention

Device:
• Capacitive-Resistive Noninvasive Radiofrequency
The two passive plates were under the back of the patient. The active capacitive plates of the machine (CAPENGERY, C200, Spain) will be applied initially for 20 minutes over the sole of both feet, with the machine adjusted on the A-thermal mode (37 oC). During the remaining 20 minutes, active capacitive plates are relocated over femoral vessels at the femoral triangle with the machine adjusted on the frank thermal mode (41 oC).

Locations

Country	Name	City	State
Egypt	Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Niajalili M, Sedaghat M, Reazasoltani A, Akbarzade Baghban AR, Sadat Naimi S. [Effect of Capacitive Tecar Therapy on Foot Pain and Tactile Sensation in Patients With Type 2 Diabetes (Persian)]. Archives of Rehabilitation. 2020; 21(3):304-319. https://doi.org/10.32598/RJ.21.3.60.5

Tashiro Y, Hasegawa S, Yokota Y, Nishiguchi S, Fukutani N, Shirooka H, Tasaka S, Matsushita T, Matsubara K, Nakayama Y, Sonoda T, Tsuboyama T, Aoyama T. Effect of Capacitive and Resistive electric transfer on haemoglobin saturation and tissue temperature. Int J Hyperthermia. 2017 Sep;33(6):696-702. doi: 10.1080/02656736.2017.1289252. Epub 2017 Feb 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the perfusion index at the end of the first session compared to baseline readings.	the perfusion index readings will be taken before the first session and set as baseline reading and after the first session and the change will be calculated.The Masimo SET "Mighty-Sat Fingertip Pulse Oximetry" (Masimo Corporation, Irvine, CA, USA model 9900) was attached to the big toe of each patient. the reading will be the the mean of three measurements of perfusion index (PI) taken at one-minute intervals.	40 minutes
Secondary	Visual Analogue Scale	Patient defines the degree of pain on a visual scale without numeric values, while the values are visible on the back side for the registrar where 0 indicates no pain and 10 indicates the most unbearable pain. The test was performed before intervention, after each session and one month after the end of all twelve sessions.	2 months
Secondary	Tactile sensation of the sole	Tactile sensation of the sole using Semmes-Weinstein monofilament 5.07/10 g. the test will be performed after each session.	2 months
Secondary	Analgesic effect	Analgesic effect after each session; will be evaluated using the four grades of WHO evaluation criteria for pain relief: Complete remission (CR); Partial remission (PR); Mild remission (MR); No response (NR).	2 months
Secondary	The total remission rate		2 months