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

NCT ID: NCT06822218

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Diabete Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High tone power therapy

30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy

Group Type EXPERIMENTAL

high tone power therapy

Intervention Type DEVICE

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.

TENS

30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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

Exclusion Criteria

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

1. Psychiatric disorders or seizures.
2. Visual and auditory impairment or tremors influencing balance.
3. Other neuromuscular disorders.
4. Foot deformities and ulcers.
5. Lower limb operations.
6. Feverish systemic infection
7. cardiac pacemaker.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Zeinab Mahmoud Awad Allah

senior of physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Om Elmasryeen Genral Hospital

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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zeinab Awadallah, master

Role: CONTACT

+201285819342

Alaa El-Moatasem, lecturer

Role: CONTACT

01006625054

Facility Contacts

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zeinab Awadallah

Role: primary

+201285819342

Other Identifiers

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P.T/REC/012/003905

Identifier Type: -

Identifier Source: org_study_id

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