Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy
Condition: Diabetic Neuropathy Peripheral
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

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.
    

Intervention name(s): High tone power therapy; Selected Physical Therapy Program
Intervention type(s): Device; Other
Intervention description(s): 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 program: (For both groups).
Wobble board training:
Active range of motion exercises (AROM):
Gentle manual stretching exercises for both UL & LL:
Graduated gait training:
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment