Actively Recruiting
High Tone Power Therapy Versus Transcutaneous Electrical Nerve Stimulation on Polyneuropathic Pain in Men with Diabetes
Led by Cairo University · Updated on 2025-02-12
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two non-drug therapies for pain caused by diabetic polyneuropathy in men aged 50 to 60 years. This study aims to find an easy and noninvasive treatment that may improve symptoms and social participation for patients with diabetic nerve pain. The results could help physiotherapists develop new approaches to managing diabetic polyneuropathy and increase knowledge about High Tone Power Therapy's effect on neuropathic pain. Sixty male patients with type 2 diabetes and polyneuropathy will be randomly assigned to one of two groups. Group A will receive High Tone Power Therapy, which uses frequencies scanned continuously from 4096 Hz to 31768 Hz, delivering up to 5000 mW of power, three times per week for 30 minutes each session over three months. Group B will receive Transcutaneous Electrical Nerve Stimulation (TENS) with frequencies ranging from 2 to 120 Hz, also three times per week for 30 minutes per session during the same three-month period. Participants will be assessed before and after treatment using tools measuring neuropathic pain (DN4 questionnaire), pain pressure threshold, glycosylated hemoglobin (HbA1c), and life disability. All patients must be ambulant and under full medical control with diabetes lasting more than 10 years. The study includes continuous monitoring for up to 12 weeks and aims to guide future clinical roles for therapists in diabetic neuropathy management.
CONDITIONS
Brief Title
High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients diagnosed with diabetic polyneuropathy aged 50 to 60 years
- Able to walk independently
- Under full medical control
- HbA1c (blood sugar control) between 6.5% and 7%
- Diabetes duration longer than 10 years
You will not qualify if you...
- Psychiatric disorders or history of seizures
- Visual or hearing impairments or tremors affecting balance
- Other neuromuscular disorders
- Foot deformities or ulcers
- History of lower limb surgeries
- Current feverish systemic infection
- Presence of a cardiac pacemaker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either high tone power therapy or transcutaneous electrical nerve stimulation (TENS) three times per week for 30 minutes per session over 3 months.
Approximately 36 treatment sessions (3 times per week)
Trial Site Locations
Total: 1 location
1
Om Elmasryeen Genral Hospital
Giza, Egypt
Actively Recruiting
Research Team
Z
zeinab Awadallah, master
A
Alaa El-Moatasem, lecturer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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