Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain

NCT ID: NCT05917249

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-07
• Study Completion Date: 2024-01-30

Brief 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.

Detailed 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.

Conditions

Diabetic Neuropathy, Painful

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

interventional

Group Type: EXPERIMENTAL

Capacitive-Resistive Noninvasive Radiofrequency

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

TECAR

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Bassant M. Abdelhamid

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Abdelrauof, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Waleed Al-Hamimy, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Medicine

Cairo, , Egypt

Countries

Egypt

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28139939 (View on PubMed)

Other Identifiers

Ms-399-2022

Identifier Type: -

Identifier Source: org_study_id