Diabete MellitusNCT06822218
High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
A study testing high tone power therapy and TENS in people with Diabete Mellitus, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- high tone power therapy and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Om Elmasryeen Genral Hospital
Giza
zeinab Awadallah, +201285819342, zeezee.awad88@hotmail.com
About this study
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
Read the 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.
- Conditions
- Diabete Mellitus
- Being tested
- high tone power therapy, TENS
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tone power therapyDevice
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.
TENSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| High tone power therapy | Experimental | 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy Receives: Device: high tone power therapy |
| TENS | Active comparator | 30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to 12 weeks
Secondary outcomes (2)
Glyclated Haemoglobin Level (HbA1c)
Increasing HbA1c level is significantly associated with increased prevalence of DPN as well as PDPN and non-painful DPN
Measured: 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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Jan 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Mahmoud Awad Allah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822218
- Sponsor's protocol ID
- P.T/REC/012/003905
- Status last verified
- Feb 2025
- First submitted
- 23 Nov 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06822218
- Acronym / sponsor ID
- P.T/REC/012/003905
- Conditions
- Diabete Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High tone power therapy | Experimental | Device: high tone power therapy30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy |
| TENS | Active comparator | Device: TENS30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patient selection will be according to the following criteria:
Key exclusion criteria (8 listed)
- The participants will be excluded if they meet one of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high tone power therapypatients 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 | High tone power therapy |
| TENSThese 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. | Device | TENS |
Primary outcome
Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)
Time frame: up to 12 weeks
t is a questionnaire has been developed to facilitate detection of neuropathic pain.total score is 10 .diagnosis of neuropathic pain is 4/10.
Pain pressure threshold algometer
Time frame: up to 12 weeks
devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure
2 secondary outcomes
Glyclated Haemoglobin Level (HbA1c)
Time frame: up to 12 weeks
life disability
Time frame: up to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tone power therapy and TENS in people with Diabete Mellitus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zeinab Awadallah, master (+201285819342, zeezee.awad88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions) (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.