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

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.

• frequency rhythmic electrical modulated stimulation. (Device), also known as FREMS: 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.

Primary outcomes

• Neuropathy severity [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)
• blood perfusion. [From enrollment to the end of treatment at 10:14days.]: effect of FREMS on blood perfusion by duplex.

Secondary outcomes

• neuropathy effect in quality of life [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)

Sex: All, ages: 40 Years to any

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.

• Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30. PMID 29709457

• Ayman abdallah., phd, Study director, Beni-Suef University