Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol.
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- What is being studied
- The protocol lists: frequency rhythmic electrical modulated stimulation., Duloxetine - low dose.
- Who it may be relevant to
- Registry conditions: Peripheral Neuropathy With Type 2 Diabetes. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Detailed description
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.
Interventions
- Device frequency rhythmic electrical modulated stimulation.
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. - Drug Duloxetine - low dose
peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.
Primary outcome measures
- Neuropathy severity [Time frame: From enrollment to the end of treatment at 10:14 days]
- blood perfusion. [Time frame: From enrollment to the end of treatment at 10:14days.]
Secondary outcome measures (1)
- neuropathy effect in quality of life [Time frame: From enrollment to the end of treatment at 10:14days.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National diabetes institute — Giza
Publications
- 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
Identifiers
NCT: NCT07645482 · FPTBSUREC/0113/14526