Diabetic Neuropathy PeripheralNCT03888872
Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy
A study testing High tone power therapy and Selected Physical Therapy Program in people with Diabetic Neuropathy Peripheral, run by October 6 University at 1 site in Egypt.
Trial summary
The purpose of the study is to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetic Neuropathy Peripheral
- What is being tested?
- High tone power therapy and Selected Physical Therapy Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2019to 10 Sep 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty type II referred diabetic neuropathy patients from both genders their ages will be ranged from 40-60 years old.
- All patients with diabetic neuropathy > 10 years having diabetes (will be examined according to the general and specific neurological evaluation sheet for diabetic neuropathy).
- All patients in the study should be ambulant independently.
- All patients should be medically stable.
- The body mass index (BMI) ranged from 20:30 Kg/m2.
- All patients will approve and sign a consent form.
Who cannot join
- Patients < 10 years having diabetes.
- Patients with musculoskeletal deformities and disorders.
- Patients with psychiatric disorders or seizures.
- Patients with visual and auditory impairment or tremors influencing balance.
- Patients with other neuromuscular disorders.
- Patients with BMI more than 30 kg/m2.
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- Patients with foot deformities and ulcers.
- Patients with cognitive impairment using mini-mental state examination (MMSE).
- Patients with lower limb operations.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy.
Read the detailed description
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys, and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn't make enough insulin.
Diabetic neuropathies (DNs) are nerve damaging disorders associated with diabetes mellitus. These conditions are thought to result from diabetic microvascular injury involving small blood vessels that supply nerves (vasa nervorum) in addition to macrovascular conditions that can culminate in diabetic neuropathy.
The most common characteristics of diabetic neuropathy (DN) are a distal, symmetrical, primarily sensory polyneuropathy affecting the feet and legs in a chronic, slowly progressive manner. The incidence and prevalence of DN associated with duration of diabetes affect up to 50% of diabetic patients. Although DN is known as the most common complications of diabetes. Diabetic neuropathy is estimated that 40% to 50% of people with diabetes will have DN within 10 years of diagnosis.
High tone power therapy (Hi Top) is the percutaneous electrical stimulation of skeletal muscles using alternative frequencies between 4.096 and 32.768 hertz to produce a muscle contraction and the treatment of diabetic neuropathy. The therapy frequency is scanned with a defined frequency. This method is called SimulFAM for Simultaneous Frequency Amplitude Modulation.
High tone power therapy (Hi Top) is a new quantum leap in the field of electro therapy. It is Electrotherapy with sinusoidal alternating currents. The high tone power therapy provides a therapy with medium frequency sine waves. The therapy is free of direct current (D.C.) components. The amplitude and the frequency are modulated simultaneously. The higher the frequency, the more energy can be introduced corresponding to the individual threshold curve of the patient's electrosensitivity.
A short-term intervention over 5 days with HiTop has the potential to immediately reduce pain with a significantly stronger analgesic effect than TENS. Particularly, the first period of intervention showed that HTEMS reduces pain to a greater extent than TENS. From a clinical point of view, HTEMS showed a promising result, especially when comparing with TENS or considering the short period of intervention time.
SIGNIFICANCE OF THE STUDY:
Diabetic neuropathy is the most common complication of diabetes. It affects the feet and legs first, followed by the hands and arms. Signs and symptoms of peripheral neuropathy are often worse at night, and include: numbness or reduced ability to feel pain or temperature changes, tingling or burning sensation, sharp pain or cramps, muscle weakness, loss of reflexes especially in the ankle and loss of balance and coordination.
Sensory nerve action potential amplitude and conduction velocity (CV) have been shown to be sensitive indicators of nerve degeneration in patients with diabetes and have been used to detect DN. Diabetic neuropathy is associated with low sensory nerve amplitude potential (SNAP) and CV.
Recently shown in a pilot study that high tone power therapy stimulation of the thigh causing isometric muscle contraction might be an effective treatment for painful diabetic neuropathy.
High tone power therapy can stimulate a large number of nerves in the thigh, might therefore lead to a spinal stimulation that in turn decreases excitability of small nerve fibers and lead to improve function of diabetic neuropathy.
So, the current study is designed to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy.
- Conditions
- Diabetic Neuropathy Peripheral
- Being tested
- High tone power therapy, Selected Physical Therapy Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tone power therapyDevice
1- High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany).
The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort. Duration: 60 min (Each one electrode to both thighs to the knee, each one electrode to both thighs to the groin). Position: lying / setting, Number of sessions: 10, Frequency of sessions: 3 times per week.
Selected Physical Therapy ProgramOther
Selected physical therapy program: (For both groups).
- Wobble board training:
- Active range of motion exercises (AROM):
- Gentle manual stretching exercises for both UL \& LL:
- Graduated gait training:
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I (Study): will consist of 20 patients with diabetic neuropathy and will receive High tone power therapy in addition to selected physical therapy program (Wobble board training, AROM exercises for both UL \& LL, gentle manual stretching exercises for both UL \& LL and graduated gait training). for 10 sessions every other day, each session for 1.45 hours (60 minutes for HiTop and 45 minutes for selected physical therapy program). Receives: Device: High tone power therapy; Other: Selected Physical Therapy Program |
| Group II | Experimental | Group II (Control): will consist of 20 patients with diabetic neuropathy and will receive selected physical therapy program only same as group I. For 10 sessions every other day, each session for 45 minutes. Receives: Other: Selected Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Nerve Conduction Velocity
Neuro pack M1 EP/EMG measuring system MEB-9200/9300
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start12 Mar 2019
- Primary completion14 Jun 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Alshimy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888872
- Sponsor's protocol ID
- P.T.REC/012/002261
- Status last verified
- Nov 2022
- First submitted
- 22 Mar 2019
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT03888872
- Acronym / sponsor ID
- P.T.REC/012/002261
- Conditions
- Diabetic Neuropathy Peripheral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 14 Jun 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 25 Mar 2019 (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.
The purpose of the study is to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy.
Detailed description
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys, and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn't make enough insulin.
Diabetic neuropathies (DNs) are nerve damaging disorders associated with diabetes mellitus. These conditions are thought to result from diabetic microvascular injury involving small blood vessels that supply nerves (vasa nervorum) in addition to macrovascular conditions that can culminate in diabetic neuropathy.
The most common characteristics of diabetic neuropathy (DN) are a distal, symmetrical, primarily sensory polyneuropathy affecting the feet and legs in a chronic, slowly progressive manner. The incidence and prevalence of DN associated with duration of diabetes affect up to 50% of diabetic patients. Although DN is known as the most common complications of diabetes. Diabetic neuropathy is estimated that 40% to 50% of people with diabetes will have DN within 10 years of diagnosis.
High tone power therapy (Hi Top) is the percutaneous electrical stimulation of skeletal muscles using alternative frequencies between 4.096 and 32.768 hertz to produce a muscle contraction and the treatment of diabetic neuropathy. The therapy frequency is scanned with a defined frequency. This method is called SimulFAM for Simultaneous Frequency Amplitude Modulation.
High tone power therapy (Hi Top) is a new quantum leap in the field of electro therapy. It is Electrotherapy with sinusoidal alternating currents. The high tone power therapy provides a therapy with medium frequency sine waves. The therapy is free of direct current (D.C.) components. The amplitude and the frequency are modulated simultaneously. The higher the frequency, the more energy can be introduced corresponding to the individual threshold curve of the patient's electrosensitivity.
A short-term intervention over 5 days with HiTop has the potential to immediately reduce pain with a significantly stronger analgesic effect than TENS. Particularly, the first period of intervention showed that HTEMS reduces pain to a greater extent than TENS. From a clinical point of view, HTEMS showed a promising result, especially when comparing with TENS or considering the short period of intervention time.
SIGNIFICANCE OF THE STUDY:
Diabetic neuropathy is the most common complication of diabetes. It affects the feet and legs first, followed by the hands and arms. Signs and symptoms of peripheral neuropathy are often worse at night, and include: numbness or reduced ability to feel pain or temperature changes, tingling or burning sensation, sharp pain or cramps, muscle weakness, loss of reflexes especially in the ankle and loss of balance and coordination.
Sensory nerve action potential amplitude and conduction velocity (CV) have been shown to be sensitive indicators of nerve degeneration in patients with diabetes and have been used to detect DN. Diabetic neuropathy is associated with low sensory nerve amplitude potential (SNAP) and CV.
Recently shown in a pilot study that high tone power therapy stimulation of the thigh causing isometric muscle contraction might be an effective treatment for painful diabetic neuropathy.
High tone power therapy can stimulate a large number of nerves in the thigh, might therefore lead to a spinal stimulation that in turn decreases excitability of small nerve fibers and lead to improve function of diabetic neuropathy.
So, the current study is designed to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: High tone power therapy, Other: Selected Physical Therapy ProgramGroup I (Study): will consist of 20 patients with diabetic neuropathy and will receive High tone power therapy in addition to selected physical therapy program (Wobble board training, AROM exercises for both UL \& LL, gentle manual stretching exercises for both UL \& LL and graduated gait training). for 10 sessions every other day, each session for 1.45 hours (60 minutes for HiTop and 45 minutes for selected physical therapy program). |
| Group II | Experimental | Other: Selected Physical Therapy ProgramGroup II (Control): will consist of 20 patients with diabetic neuropathy and will receive selected physical therapy program only same as group I. For 10 sessions every other day, each session for 45 minutes. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Forty type II referred diabetic neuropathy patients from both genders their ages will be ranged from 40-60 years old.
- All patients with diabetic neuropathy > 10 years having diabetes (will be examined according to the general and specific neurological evaluation sheet for diabetic neuropathy).
- All patients in the study should be ambulant independently.
- All patients should be medically stable.
- The body mass index (BMI) ranged from 20:30 Kg/m2.
Key exclusion criteria (9 listed)
- Patients < 10 years having diabetes.
- Patients with musculoskeletal deformities and disorders.
- Patients with psychiatric disorders or seizures.
- Patients with visual and auditory impairment or tremors influencing balance.
- Patients with other neuromuscular disorders.
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 |
|---|---|---|
| High tone power therapy1- High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany). The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort. Duration: 60 min (Each one electrode to both thighs to the knee, each one electrode to both thighs to the groin). Position: lying / setting, Number of sessions: 10, Frequency of sessions: 3 times per week. | Device | Group I |
| Selected Physical Therapy ProgramSelected physical therapy program: (For both groups). 1. Wobble board training: 2. Active range of motion exercises (AROM): 3. Gentle manual stretching exercises for both UL \& LL: 4. Graduated gait training: | Other | Group I, Group II |
Primary outcome
Measuring Nerve Conduction Velocity
Time frame: Up to 30 days
Neuro pack M1 EP/EMG measuring system MEB-9200/9300
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 1 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High tone power therapy and Selected Physical Therapy Program in people with Diabetic Neuropathy Peripheral, run by October 6 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 6 inclusion and 9 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 1 Dec 2022. 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?
Measuring Nerve Conduction Velocity (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2022.