Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol. (FREMS)
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.
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:
- 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.
- 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.
- To compare the results between both interventional and control group.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ibtihal Nassar, Bsc, Msc.
- Telefonnummer: +201151678506
- E-post: scholaribtihal@gmail.com
Studera Kontakt Backup
- Namn: Ibtihal Nassar
- Telefonnummer: 01151678506
- E-post: scholaribtihal@gmail.com
Studieorter
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Giza, Egypten
- National diabetes institute
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Kontakt:
- Ibtihal Nassar, Bsc, Msc.
- Telefonnummer: +201151678506
- E-post: scholaribtihal@gmail.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: (FREMS group)
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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.
Andra namn:
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Aktiv komparator: conservative treatment.
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peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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blood perfusion.
Tidsram: From enrollment to the end of treatment at 10:14days.
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effect of FREMS on blood perfusion by duplex.
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From enrollment to the end of treatment at 10:14days.
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Neuropathy severity
Tidsram: From enrollment to the end of treatment at 10:14 days
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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) |
From enrollment to the end of treatment at 10:14 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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neuropathy effect in quality of life
Tidsram: From enrollment to the end of treatment at 10:14days.
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neuropathy effect on quality of life by NORFOLK quality of life questionnaire.
136 = Worst possible quality of life (maximum neuropathy-related impairment)
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From enrollment to the end of treatment at 10:14days.
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Ayman abdallah., phd, Beni-Suef University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FPTBSUREC/0113/14526
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