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NCT Number: NCT06822218

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

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

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Key information

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

High Tone Power Therapy

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

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.

Primary outcomes

  1. Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)

    Time frame: up to 12 weeks

    t is a questionnaire has been developed to facilitate detection of neuropathic pain.total score is 10 .diagnosis of neuropathic pain is 4/10.

  2. Pain pressure threshold algometer

    Time frame: up to 12 weeks

    devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure

Secondary outcomes

  1. Glyclated Haemoglobin Level (HbA1c)

    Time frame: up to 12 weeks

    Increasing HbA1c level is significantly associated with increased prevalence of DPN as well as PDPN and non-painful DPN

  2. life disability

    Time frame: up to 12 weeks

    the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) is an abbreviated, 26-item version of the 100-item WHOQOL-100 quality of life measure. The WHOQOL-BREF addresses four quality of life domains: physical health, psychological health, social relationships and environment. Then calculate a domain score for each of the health domains by calculating the average answer points for each domain (sum of answer points divided by number of questions) and multiplying the result by the number 4.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa El-Moatasem, lecturer

CONTACT

[email protected]

01006625054

zeinab Awadallah, master

CONTACT

[email protected]

+201285819342

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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