High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high tone power therapy, TENS.
- Who it may be relevant to
- Registry conditions: Diabete Mellitus. Basic parameters: 50 years — 60 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- 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. - 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.
Primary outcome measures
- Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions) [Time frame: up to 12 weeks]
- Pain pressure threshold algometer [Time frame: up to 12 weeks]
Secondary outcome measures (2)
- Glyclated Haemoglobin Level (HbA1c) [Time frame: up to 12 weeks]
- life disability [Time frame: up to 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Om Elmasryeen Genral Hospital — Giza
Identifiers
NCT: NCT06822218 · P.T/REC/012/003905