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

Cairo University (CU)

Status: Enrolling

Conditions: Diabete Mellitus

Treatments: Device: high tone power therapy; Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT06822218

P.T/REC/012/003905

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

High tone power therapy

Experimental group

Description:

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

Treatment:

Device: high tone power therapy

TENS

Active Comparator group

Description:

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

Treatment:

Device: TENS