Health TrialsbyHealthPanel

Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol.

ConditionPeripheral Neuropathy With Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBeni-Suef University

About this trial

It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence \[14\], the goal of the study is to investigate this problem through the following objectives:

1. To measure the effect of using FREMS therapy in diabetic neuropathy in interventional group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline. 2. To measure the effect of using standard of care in diabetic neuropathy in control group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline. 3. To compare the results between both interventional and control group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients diagnosed with DM

patients age group above 40 years old.

patient diagnosed with peripheral neuropathy with symptoms lasts more than 3 months.

patients lower limb ischemia in duplex affected APSV.

Disqualifiers

patients with implant peacemakers, defibrillator, or neurostimulator.

pregnancy.

any severe disease prevent compliance to study procedures.

patients with disabilities prevent their commitment to sessions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • frequency rhythmic electrical modulated stimulation.

    Device

    FREMS is characterized by sequences of biphasic electrical stimuli, with 10 consecutive sessions applied on lower limb within 10:14 days, 40 minutes for each session.

  • Duloxetine - low dose

    Drug

    peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: (FREMS group)Experimental treatment 1 intervention
Group B: conservative treatment.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neuropathy severity

neuropathy symptoms like (tingling, numbness, pain, loss of sensation) will be measured through neuropathy impairment score(NIS). The higher the score the worst the symptoms are. 0 = No neurological impairment 244 = Complete loss of the assessed motor, reflex, and sensory functions (theoretical maximum)

Time frame
From enrollment to the end of treatment at 10:14 days
2

blood perfusion.

effect of FREMS on blood perfusion by duplex.

Time frame
From enrollment to the end of treatment at 10:14days.

Secondary outcomes

1

neuropathy effect in quality of life

neuropathy effect on quality of life by NORFOLK quality of life questionnaire. 136 = Worst possible quality of life (maximum neuropathy-related impairment)

Time frame
From enrollment to the end of treatment at 10:14days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: