First Relief Treatment for Peripheral Neuropathy

Study Overview
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Brief Summary
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To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.

Official Title
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To Prove the Effectiveness of PENS Therapy With Peripheral Neuropathy

Conditions
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Peripheral Neuropathy

Intervention / Treatment
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* Device: First Relief Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Neuropathy pain Exclusion Criteria: Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard stimulation<br>Group A will be treated with First Relief Treatment at standard stimulation. | Device: First Relief Treatment<br>* To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.<br>|
| Experimental: sweep stimulation<br>Group B will be treated with First Relief Treatment at sweep stimulation. | Device: First Relief Treatment<br>* To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.<br>|
| Experimental: Placebo<br>Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation) | Device: First Relief Treatment<br>* To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Neuropathy pain | This treatments effective outcome will be, Percutaneous Electrical Nerve Stimulation therapy will have the ability to reduce the pain and other conditions regarding peripheral neuropathy which can be verified through Biothesiometer parameters. | According to the patients condition and other factors expected to reduce pain in 4th week of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Check for delay of Re-occurrence of pain within a short time | After the treatment of 4th week the pain will be reduced and the treatment is continued for other 3 weeks where the booster dose is applied for the assurance of delay of pain which is evaluated manually by the medical personals after 90 days of booster dose treatment | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First Relief, Diebetes, Pheripheral Neuropathy, Pain Releif