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

9. juni 2026 opdateret af: Ibtihal Nassar, Beni-Suef University

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:

  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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiesteder

Deltagelseskriterier

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Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

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Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: (FREMS group)
Enhed: 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.
Andre navne:
  • FREMS
Aktiv komparator: conservative treatment.
Medicin: Duloxetine - low dose
peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neuropathy severity
Tidsramme: 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)
From enrollment to the end of treatment at 10:14 days
blood perfusion.
Tidsramme: From enrollment to the end of treatment at 10:14days.
effect of FREMS on blood perfusion by duplex.
From enrollment to the end of treatment at 10:14days.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
neuropathy effect in quality of life
Tidsramme: From enrollment to the end of treatment at 10:14days.
neuropathy effect on quality of life by NORFOLK quality of life questionnaire.
From enrollment to the end of treatment at 10:14days.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

Efterforskere

  • Studieleder: Ayman abdallah., phd, Beni-Suef University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FPTBSUREC/0113/14526

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med frequency rhythmic electrical modulated stimulation.

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