Clinical trial NCT03888872: Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy
Official title: Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy Peripheral
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Forty type II referred diabetic neuropathy patients from both genders their ages will be ranged from 40-60 years old.
2. All patients with diabetic neuropathy \> 10 years having diabetes (will be examined according to the general and specific neurological evaluation sheet for diabetic neuropathy).
3. All patients in the study should be ambulant independently.
4. All patients should be medically stable.
5. The body mass index (BMI) ranged from 20:30 Kg/m2.
6. All patients will approve and sign a consent form.

Exclusion Criteria:

1. Patients \< 10 years having diabetes.
2. Patients with musculoskeletal deformities and disorders.
3. Patients with psychiatric disorders or seizures.
4. Patients with visual and auditory impairment or tremors influencing balance.
5. Patients with other neuromuscular disorders.
6. Patients with BMI more than 30 kg/m2.
7. Patients with foot deformities and ulcers.
8. Patients with cognitive impairment using mini-mental state examination (MMSE).
9. Patients with lower limb operations.

Primary outcomes:
measure: Measuring Nerve Conduction Velocity
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: El-Sheikh Zayed City
country: Egypt
facility: October 6 University
state: Giza
Study officials:
References: