Diabetic Neuropathy, PainfulNCT05917249
Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain
A study testing Capacitive-Resistive Noninvasive Radiofrequency in people with Diabetic Neuropathy, Painful, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- Capacitive-Resistive Noninvasive Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jun 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study
Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease in foot sensation. Therefore, the treatment of this disorder is very important.
Read the 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
- Being tested
- Capacitive-Resistive Noninvasive Radiofrequency
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacitive-Resistive Noninvasive RadiofrequencyDevice
Also called TECAR
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).
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | Not described Receives: Device: Capacitive-Resistive Noninvasive Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 minutes
Secondary outcomes (4)
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.
Measured: 2 months
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.
Measured: 2 months
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).
Measured: 2 months
The total remission rate
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start7 Jun 2023
- Primary completion1 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Mohamed Abdelrauof, MD, Principal investigator, Cairo UniversityWaleed Al-Hamimy, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917249
- Sponsor's protocol ID
- Ms-399-2022
- Status last verified
- Feb 2024
- First submitted
- 5 Jun 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28139939
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Capacitive-Resistive Noninvasive Radiofrequency in Improving Perfusion Index and Attenuating Diabetic Neuropathic Pain; A Pre-post Study
- ClinicalTrials.gov ID
- NCT05917249
- Acronym / sponsor ID
- Ms-399-2022
- Conditions
- Diabetic Neuropathy, Painful
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Device: Capacitive-Resistive Noninvasive Radiofrequency |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capacitive-Resistive Noninvasive RadiofrequencyAlso: TECARThe 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). | Device | interventional |
Primary outcome
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.
4 secondary outcomes
Visual Analogue Scale
Time frame: 2 months
Tactile sensation of the sole
Time frame: 2 months
Analgesic effect
Time frame: 2 months
The total remission rate
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- BackgroundNiajalili 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
- Background: PubMed 28139939Tashiro 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abdelrauof, MD principal investigator
Cairo University
Waleed Al-Hamimy, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacitive-Resistive Noninvasive Radiofrequency in people with Diabetic Neuropathy, Painful, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the perfusion index at the end of the first session compared to baseline readings. (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05917249, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.