Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain
Can a Non-interventional Pulsed Radiofrequency Device Relieve Pain and Improve Function in Patients With Diabetic Neuropathy That Are Refractory to Medication? A Single Blind Randomized Placebo-controlled Trial
The purpose of this study is to determine if a non-invasive, electrical pulsed radio frequency (PRF) device can relieve pain and improve function in patients suffering from diabetic nerve pain in their feet, known as pedal diabetic peripheral neuropathy. Patients with this condition often experience severe pain, burning sensations, numbness, and tingling. Current medications for diabetic nerve pain often have unwanted side effects or do not provide sufficient relief.
In this single-blind, randomized trial, participants are assigned to receive either an active PRF treatment or a placebo (sham) treatment. Both treatments involve placing the device safely behind the knee (targeting the sciatic nerve) for 10 minutes, once a week for 3 weeks. The main question this study aims to answer is whether the active PRF treatment reduces nerve pain and symptoms significantly more than the placebo, measured by standard symptom questionnaires over a 6-month period.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes, often presenting as a chronic, symmetrical, length-dependent sensorimotor polyneuropathy. Patients frequently experience neuropathic pain, hyperalgesia, allodynia, and paraesthesia in the lower extremities. Because pharmacological treatments for painful DPN are often ineffective and complicated by adverse side effects, there is a significant unmet clinical need for alternative, non-pharmacological therapies. This single-blind, randomized, placebo-controlled clinical trial evaluates the efficacy of a transcutaneous electrical pulsed radio frequency (PRF) device in alleviating the pain and sensory symptoms associated with pedal DPN.
Patients diagnosed with pedal DPN who scored 4 or higher on the DN4 neuropathic pain diagnostic test were randomized into two parallel groups: an active treatment group and a placebo group. To ensure successful patient blinding, participants were advised that they might not feel a physical sensation during the treatment, which aligns with the natural sensory loss (numbness/paraesthesia) commonly experienced by this patient population. Care providers and investigators administering the interventions were unblinded.
The treatment protocol involved mapping the sciatic nerve in the popliteal fossa posteriorly at the knee. The active or placebo device was then applied bilaterally at this site for 10 minutes. Interventions were administered once weekly for three consecutive weeks.
Clinical efficacy was assessed using validated patient-reported outcome measures. The primary outcome evaluated changes in neuropathic pain and symptoms using the DN4 test, while the secondary outcome measured pain severity and interference with daily life using the Brief Pain Inventory-Short Form (BPI-SF). Data was collected at baseline, immediately following the third treatment, and at subsequent follow-up visits at 1, 3, and 6 months to evaluate both immediate and sustained therapeutic effects.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gauteng
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Johannesburg, Gauteng, Sudáfrica
- Centre for Diabetes and Endocrinology (CDE), Houghton
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Johannesburg, Gauteng, Sudáfrica
- Clinical Sites - West Johannesburg
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Johannesburg, Gauteng, Sudáfrica
- Diabetic Clinic at the Charlotte Maxeke Hospital
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Krugersdorp, Gauteng, Sudáfrica
- Clinical Sites - Krugersdorp
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Pretoria, Gauteng, Sudáfrica
- CDE / Clinical Sites - Pretoria
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosis of pedal Diabetic Peripheral Neuropathy.
- A score of 4 or greater than 4/10 on the DN4 Test.
- Naive to (no previous experience with) the electrical pulsed radio frequency current treatment.
Exclusion Criteria:
- Current pregnancy.
- Presence of a pacemaker.
- Presence of a peripheral or spinal cord stimulator.
- Presence of metal implants in the knee and/or hip.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group A: Active Transcutaneous Pulsed Radio Frequency
Patients in this group received the active electrical pulsed radiofrequency current treatment.
The device was applied bilaterally at the sciatic nerve in the popliteal fossa.
Each treatment session lasted for 10 minutes.
The intervention was administered once weekly for three consecutive weeks.
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Active transcutaneous electrical pulsed radio frequency stimulation.
The device is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks.
Otros nombres:
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Comparador falso: Group B: Placebo / Sham Device
Patients in this group received a placebo (sham) treatment designed to mimic the active device.
The placebo device was applied bilaterally at the sciatic nerve in the popliteal fossa.
Each placebo session lasted for 10 minutes.
The sham intervention was administered once weekly for three consecutive weeks.
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A sham device designed to look and operate like the active device but delivering no therapeutic current.
It is applied bilaterally at the sciatic nerve in the popliteal fossa for 10 minutes, once weekly for 3 consecutive weeks to mimic the active treatment.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Neuropathic Pain and Symptoms as Measured by the DN4 Test
Periodo de tiempo: Baseline, prior to the third treatment (Week 3), and at 1, 3, and 6 months after the last treatment.
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The DN4 (Douleur Neuropathique 4) questionnaire is a screening tool used to identify neuropathic pain and symptoms.
It consists of 7 subjective questions regarding sensory symptoms (e.g., burning, painful cold, electric shocks, tingling, pins and needles, numbness) and 3 objective tests (hypoesthesia to touch, pinprick, and tactile allodynia).
The maximum score is 10 points.
A score of 4 or greater out of 10 represents a positive diagnosis of neuropathic pain.
Higher scores indicate a greater severity of neuropathic pain and symptoms.
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Baseline, prior to the third treatment (Week 3), and at 1, 3, and 6 months after the last treatment.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Periodo de tiempo: Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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The BPI-SF is a validated patient-reported questionnaire that evaluates pain.
This outcome focuses on the Pain Severity subscale, which assesses worst, least, average, and present pain using an 11-point numerical rating scale.
Scores range from 0 to 10, where 0 equals "no pain" and 10 equals "pain as bad as you can imagine".
Higher scores indicate greater pain severity.
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Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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Change in Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
Periodo de tiempo: Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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The BPI-SF also evaluates how much pain interferes with various aspects of the patient's daily life.
This includes general activities, work, sleep, walking ability, mood, relations with other people, and overall quality of life.
Interference is measured using an 11-point numerical rating scale ranging from 0 to 10, where 0 equals "does not interfere" and 10 equals "completely interferes".
Higher scores indicate greater interference with daily functioning.
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Baseline, after the first treatment (Week 1), second treatment (Week 2), third treatment (post-treatment at Week 3), and at 1, 3, and 6 months after the last treatment.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Phyllis P Berger, Faculty: University of the Witwatersrand
- Director de estudio: Stanley S Landau, Centre for Diabetes and Endocrinology (CDE)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del sistema endocrino
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Diabetes mellitus
- Angiopatías diabéticas
- Complicaciones de la diabetes
- Enfermedades de la piel
- Úlcera de la piel
- Úlcera en la pierna
- Neuropatías diabéticas
- Úlcera del pie
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Neuralgia
- Pie diabético
Otros números de identificación del estudio
- M161037
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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