Clinical trial NCT05917249: Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain
Official title: Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of the perfusion index at the end of the first session compared to baseline readings.
timeFrame: 40 minutes
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 2 months
measure: Tactile sensation of the sole
timeFrame: 2 months
measure: Analgesic effect
timeFrame: 2 months
measure: The total remission rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Medicine
Study officials:
affiliation: Cairo University
name: Mohamed Abdelrauof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Waleed Al-Hamimy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.