An interventional study of high tone power therapy and TENS in Diabete Mellitus, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to male participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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The patient selection will be according to the following criteria:
Exclusion Criteria:
The participants will be excluded if they meet one of the following criteria:
30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy
Device: high tone power therapy
30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS
Device: TENS
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.
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.
Time frame: 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
Time frame: up to 12 weeks
Glyclated Haemoglobin Level (HbA1c)
Increasing HbA1c level is significantly associated with increased prevalence of DPN as well as PDPN and non-painful DPN
Time frame: 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.
Time frame: up to 12 weeks
Plan to share: No
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Cairo University