Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Change of the perfusion index at the end of the first session compared to baseline readings.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change of the perfusion index at the end of the first session compared to baseline readings.
Time Frame: 40 minutes
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.
Secondary Outcomes
- Visual Analogue Scale(2 months)
- Tactile sensation of the sole(2 months)
- The total remission rate(2 months)
- Analgesic effect(2 months)
Investigators
Bassant M. Abdelhamid
Professor
Cairo University