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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ibtihal Nassar, Bsc, Msc.
- Numéro de téléphone: +201151678506
- E-mail: scholaribtihal@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Ibtihal Nassar
- Numéro de téléphone: 01151678506
- E-mail: scholaribtihal@gmail.com
Lieux d'étude
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Giza, Egypte
- National diabetes institute
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Contact:
- Ibtihal Nassar, Bsc, Msc.
- Numéro de téléphone: +201151678506
- E-mail: scholaribtihal@gmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: (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.
Autres noms:
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Comparateur actif: conservative treatment.
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peripheral neuropathy conventional treatment, 30:60mg orally once/day within 10:14 days.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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blood perfusion.
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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neuropathy effect in quality of life
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Ayman abdallah., phd, Beni-Suef University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FPTBSUREC/0113/14526
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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