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Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathy Peripheral

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High tone power therapy
Selected Physical Therapy Program
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy Peripheral

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • October 6 University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I

Group II

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Measuring Nerve Conduction Velocity
Neuro pack M1 EP/EMG measuring system MEB-9200/9300

Secondary Outcome Measures

Full Information

First Posted
March 22, 2019
Last Updated
November 30, 2022
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT03888872
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
June 14, 2020 (Actual)
Study Completion Date
September 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy Peripheral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
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).
Arm Title
Group II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High tone power therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Selected Physical Therapy Program
Intervention Description
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:
Primary Outcome Measure Information:
Title
Measuring Nerve Conduction Velocity
Description
Neuro pack M1 EP/EMG measuring system MEB-9200/9300
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Patients with foot deformities and ulcers. Patients with cognitive impairment using mini-mental state examination (MMSE). Patients with lower limb operations.
Facility Information:
Facility Name
October 6 University
City
El-Sheikh Zayed City
State/Province
Giza
ZIP/Postal Code
1133
Country
Egypt

12. IPD Sharing Statement

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Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy

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