Hyperbaric Oxygen Therapy Versus High Power Laser for Diabetic Neuropathy (HBOT-HPLT-DPN)
Hyperbaric Oxygen Therapy Versus High Power Laser Therapy On Sensorimotor Functions In Patients With Diabetic Peripheral Neuropathy
The purpose of this study is to compare the clinical effects of Hyperbaric Oxygen Therapy (HBOT) versus High-Intensity Laser Therapy (HPLT) on sensorimotor functions and nerve conduction in patients suffering from painful diabetic peripheral neuropathy.
Participants are divided into three equal groups. The first group receives a traditional physiotherapy program focused on ankle and foot exercises. The second group receives hyperbaric oxygen therapy sessions in addition to the traditional program. The third group receives high-power MLS laser therapy alongside the traditional program. Investigators look at whether either advanced intervention shows superiority in improving nerve functionality and reducing neuropathic pain.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Diabetic peripheral neuropathy (DPN) is a major microvascular complication of diabetes leading to progressive nerve damage and neuropathic pain. This randomized controlled trial evaluates and compares the efficacy of two non-pharmacological interventions: Hyperbaric Oxygen Therapy (HBOT) and High-Intensity Laser Therapy (HPLT).
A total of 66 medically controlled patients with painful diabetic neuropathy are randomly assigned into three equal parallel groups (22 patients per group):
- Control Group (A): Receives a traditional physiotherapy program including foot and ankle ROM exercises, strengthening, and functional walking training for 5 sessions per week for 3 weeks.
- Study Group (B): Receives Hyperbaric Oxygen Therapy (100% oxygen at 2.5 ATA for 60 minutes, totaling 90 minutes per session) for 15 sessions over 3 weeks, combined with the traditional physiotherapy program.
- Study Group (C): Receives High-Power Laser Therapy using a Multiwave Locked System (MLS) laser device (1500 Hz frequency) applied every other day for 9 sessions over 3 weeks, combined with the traditional physiotherapy program.
Assessments are conducted before and after the 3-week treatment period using objective Nerve Conduction Studies (NCS) for the sural and common peroneal nerves, and subjective screening via the Arabic Michigan Neuropathy Screening Instrument (MNSI) score.
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo Governorate
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Cairo, Cairo Governorate, Egipto, 11771
- Kobri El Koba Military Hospital
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients diagnosed with type 2 diabetes mellitus for more than 5 years.
- Presence of painful diabetic peripheral neuropathy lasting for more than 6 months.
- Presence of sensory abnormalities, burning pain, and impaired nerve conduction velocity in the lower extremities.
- Medically controlled glycemic status.
- Sufficient cognitive abilities with a Mini-Mental State Examination (MMSE) score greater than 24.
- Fit for hyperbaric pressure therapy with a cardiac ejection fraction (CEF) equal to or greater than 50% and blood pressure equal to or less than 150/90 mmHg.
Exclusion Criteria:
- Peripheral neuropathy resulting from causes other than diabetes (e.g., vitamin B12 deficiency, alcohol abuse, or trauma).
- Severe vascular insufficiency in the lower limbs.
- Uncontrolled medical conditions such as tumors or thyroid dysfunction.
- Pregnancy.
- Presence of metallic implantations or cardiac pacemakers.
- Severe visual, auditory, or cognitive impairment (MMSE score less than 24).
- Chronic obstructive pulmonary disease (COPD) or other contraindications to hyperbaric oxygen therapy.
- History of other neurological diseases (e.g., stroke or multiple sclerosis).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: Conventional Physiotherapy
Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks). |
Foot and ankle range of motion (ROM) exercises, strengthening exercises, functional exercises, and walking training (5 sessions per week for 3 weeks) |
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Experimental: Hyperbaric Oxygen Therapy (HBOT)
Conventional physiotherapy program plus HBOT sessions (100% oxygen at 2.5 ATA for 60 minutes, with 15 minutes gradual compression and 15 minutes decompression, totaling 90 minutes per session). 15 sessions over 3 weeks. |
100% oxygen inhalation at 2.5 ATA pressure for 60 minutes inside a hyperbaric chamber.
Otros nombres:
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Experimental: High-Power Laser Therapy (HPLT)
Conventional physiotherapy program plus HPLT (MLS laser, M6). Applied every other day for 9 sessions over 3 weeks. Includes a remote foot scan followed by contact application on 7 specific lower extremity areas. |
MLS laser (M6 device) at 1500 Hz frequency, applied every other day for 9 sessions over 3 weeks. Includes a remote foot scan followed by contact application on 7 specific lower extremity areas.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Michigan Neuropathy Screening Instrument (MNSI) score
Periodo de tiempo: Baseline and 3 weeks post-treatment
|
The Michigan Neuropathy Screening Instrument (MNSI) questionnaire was used to assess symptoms of diabetic peripheral neuropathy. Abnormal responses were summed to obtain the total score. The questionnaire score ranges from 0 to 13, with higher scores indicating greater neuropathic symptom burden. |
Baseline and 3 weeks post-treatment
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|
Change in right sural nerve distal sensory latency
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Right sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
Baseline and after 3 weeks of treatment
|
|
Change in left sural nerve distal sensory latency
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Left sural nerve distal sensory latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
Baseline and after 3 weeks of treatment
|
|
Change in right sural nerve sensory amplitude
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Right sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV). |
Baseline and after 3 weeks of treatment
|
|
Change in left sural nerve sensory amplitude
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Left sural nerve sensory amplitude was assessed using nerve conduction studies and measured in microvolts (µV). |
Baseline and after 3 weeks of treatment
|
|
Change in right sural nerve conduction velocity
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Right sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
Baseline and after 3 weeks of treatment
|
|
Change in left sural nerve conduction velocity
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Left sural nerve conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
Baseline and after 3 weeks of treatment
|
|
Change in right peroneal nerve distal motor latency
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Right peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
Baseline and after 3 weeks of treatment
|
|
Change in left peroneal nerve distal motor latency
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Left peroneal nerve distal motor latency was assessed using nerve conduction studies and measured in milliseconds (ms). |
Baseline and after 3 weeks of treatment
|
|
Change in right peroneal nerve motor amplitude
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Right peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV). |
Baseline and after 3 weeks of treatment
|
|
Change in left peroneal nerve motor amplitude
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Left peroneal nerve motor amplitude was assessed using nerve conduction studies and measured in millivolts (mV). |
Baseline and after 3 weeks of treatment
|
|
Change in right peroneal nerve motor conduction velocity
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Right peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
Baseline and after 3 weeks of treatment
|
|
Change in left peroneal nerve motor conduction velocit
Periodo de tiempo: Baseline and after 3 weeks of treatment
|
Left peroneal nerve motor conduction velocity was assessed using nerve conduction studies and measured in meters per second (m/s). |
Baseline and after 3 weeks of treatment
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- P.T.REC/012/005181
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared outside the research team to maintain patient privacy and data confidentiality in accordance with institutional guidelines.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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