Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain
Primary Purpose
Diabetic Neuropathy, Painful
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Capacitive-Resistive Noninvasive Radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Painful
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.
Sites / Locations
- MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
interventional
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
The total remission rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05917249
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Capacitive-Resistive Noninvasive Radiofrequency
Other Intervention Name(s)
TECAR
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change of the perfusion index at the end of the first session compared to baseline readings.
Description
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.
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
2 months
Title
Tactile sensation of the sole
Description
Tactile sensation of the sole using Semmes-Weinstein monofilament 5.07/10 g. the test will be performed after each session.
Time Frame
2 months
Title
Analgesic effect
Description
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).
Time Frame
2 months
Title
The total remission rate
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant Abdelhamid, MD
Phone
01224254012
Email
bassantmohamed197@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heba Mohamed, Msc
Email
hebamohammed94h13@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdelrauof, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waleed Al-Hamimy, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine
City
Cairo
ZIP/Postal Code
1772
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassant abdelhamid
Phone
01224254012
Email
bassantmohamed197@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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
Results Reference
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PubMed Identifier
28139939
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.
Results Reference
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Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain
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