High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
1 other identifier
interventional
60
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedFebruary 12, 2025
February 1, 2025
2.2 years
November 23, 2022
February 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Glyclated Haemoglobin Level (HbA1c)
up to 12 weeks
life disability
up to 12 weeks
Study Arms (2)
High tone power therapy
EXPERIMENTAL30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy
TENS
ACTIVE COMPARATOR30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Om Elmasryeen Genral Hospital
Giza, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- senior of physiotherapy
Study Record Dates
First Submitted
November 23, 2022
First Posted
February 12, 2025
Study Start
January 1, 2023
Primary Completion
February 28, 2025
Study Completion
February 28, 2025
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share