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NCT Number: NCT07645482

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

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.

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Key information

Conditions

Peripheral Neuropathy With Type 2 Diabetes

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

There are no clear guidelines for the treatment of peripheral neuropathy. While the American Diabetes Association stresses the importance of early detection and preventive measures, diagnosis and management are still on a developing path.

drugs used have common side effects; duloxetine and pregabalin patients are prone to nausea, fatigue, constipation, and decreased appetite; antidepressants may cause drowsiness, dry mouth, and muscle weakness; and opioids are prevented for long-term use due to the risk of addiction in all chronic cases like peripheral neuropathy. And most of the studies on these medications didn't report quality of life effects.

the lack of clear safe treatments with long-term effects on function and quality of life is the motive to conduct a randomized controlled trial on an objective assessment tool like duplex and a valid and reliable diagnostic tool like the neuropathy impairment score(NIS), measuring the effect of treatment on quality of life by the NORFOLK quality of life questionnaire after treatment with safe nonpharmacological treatment like FREMS therapy.

cases will be referred to the physiotherapy department by a diagnosis of peripheral neuropathy. samples will be assessed and divided into two groups randomly, Group A that will conduct a session with APTIVA FREMS therapy. Group B that will follow the conservative used treatment (doulextine and vitamin supplements) only.

The Number of sessions is 10 sessions consecutively within 10:14 days. The patients will be assessed by full neurological examination through the duplex APSV, neuropathy impairment score and NORFOLK quality of life questionnaire before and after the treatment.

outcomes will be collected by the researcher.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • patients with implant peacemakers, defibrillator, or neurostimulator.
  • pregnancy.
  • any severe disease prevent compliance to study procedures.
  • patients with disabilities prevent their commitment to sessions.

Treatment and study plan

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.

Other names: FREMS

Duloxetine - low dose

Drug

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

Primary outcomes

  1. Neuropathy severity

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

    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)

  2. blood perfusion.

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

    effect of FREMS on blood perfusion by duplex.

Secondary outcomes

  1. neuropathy effect in quality of life

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ibtihal Nassar

CONTACT

[email protected]

01151678506

Ibtihal Nassar, Bsc, Msc.

CONTACT

[email protected]

+201151678506

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effects Of Frequency Rhythmic Electrical Modulated Stimulation (FREMS) On Blood Perfusion, Neuropathy Severity And Quality Of Life In Diabetic Patients With Peripheral Neuropathy And Lower Limb Ischemia: A Randomized Controlled Trial.

Acronym: FREMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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