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

Study Overview

• Status: Recruiting
• Conditions: Diabete Mellitus
• Intervention / Treatment: Device: high tone power therapy; Device: TENS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa El-Moatasem, lecturer; Phone Number: 01006625054; Email: alaamotasem@rocketmail.com
• Study Contact Backup: Name: zeinab Awadallah, master; Phone Number: +201285819342; Email: zeezee.awad88@hotmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Om Elmasryeen Genral Hospital
    • Contact: zeinab Awadallah; Phone Number: +201285819342; Email: zeezee.awad88@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High tone power therapy; 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy	Device: 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.
Active Comparator: TENS; 30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)	t is a questionnaire has been developed to facilitate detection of neuropathic pain.total score is 10 .diagnosis of neuropathic pain is 4/10.	up to 12 weeks
Pain pressure threshold algometer	devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glyclated Haemoglobin Level (HbA1c)	Increasing HbA1c level is significantly associated with increased prevalence of DPN as well as PDPN and non-painful DPN	up to 12 weeks
life disability	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.	up to 12 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: P.T/REC/012/003905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes