High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients

Обзор

the results of this study may provide an easy non pharmacological modality for dealing with diabetic polyneuropathic pain. Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of diabetic polyneuropathy. In Addition, increased knowledge of the influence of High tone power therapy on neuropathic pain

Подробное описание

This study will be carried out on sixty diabetic male patients with polyneuropathy with ages 50-60 years . Patient will be randomly assigned to two grouos. group A will include 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced for 3 times per week, for 3 months for 30 minutes every session.

Group B :

This group will include 30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS with applied frequencies range from 2 to 120 Hz. for 3 times per week for 30 minutes every session during 3 months of intervention.

Вмешательства

• Устройство high tone power therapy
  patients will be assigned into 2 groups with pre and post treatment protocol application. all patients will be thoroughly evaluated before and after treatment protocol application.
• Устройство TENS
  These patients will receive TENS with applied frequencies range from 2 to 120 Hz. for 3 times per week for 30 minutes every session during 3 months of intervention in addition to medications.

Первичные конечные точки

• Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions) [Срок оценки: up to 12 weeks]
• Pain pressure threshold algometer [Срок оценки: up to 12 weeks]

Вторичные конечные точки (2)

• Glyclated Haemoglobin Level (HbA1c) [Срок оценки: up to 12 weeks]
• life disability [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• The patient selection will be according to the following criteria:

• Sixty male patients are diagnosed with diabetic polyneuropathy their ages will be ranged from 50-60 years old.
• All patients are ambulant independently.
• All patients are under full medical control
• HbA1c is ranged from 6.5 : 7 %.
• Patients has diabetes more than 10 years.

Критерии исключения

• The participants will be excluded if they meet one of the following criteria:

• Psychiatric disorders or seizures.
• Visual and auditory impairment or tremors influencing balance.
• Other neuromuscular disorders.
• Foot deformities and ulcers.
• Lower limb operations.
• Feverish systemic infection
• cardiac pacemaker.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Om Elmasryeen Genral Hospital — Giza

Идентификаторы

NCT: NCT06822218 · P.T/REC/012/003905

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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