First Relief Treatment for Peripheral Neuropathy

NCT ID: NCT03540446

Last Updated: 2018-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2018-10-31

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.

Detailed Description

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Conditions

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Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard stimulation

Group A will be treated with First Relief Treatment at standard stimulation.

Group Type EXPERIMENTAL

First Relief Treatment

Intervention Type DEVICE

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

sweep stimulation

Group B will be treated with First Relief Treatment at sweep stimulation.

Group Type EXPERIMENTAL

First Relief Treatment

Intervention Type DEVICE

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

Placebo

Group C will be treated with First Relief Treatment, receiving a placebo.(dummy device with no electrical stimulation)

Group Type EXPERIMENTAL

First Relief Treatment

Intervention Type DEVICE

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

Interventions

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First Relief Treatment

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

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DyAnsys, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Gurunath, Ph.D

Role: STUDY_DIRECTOR

Jeevak hospital

Locations

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Clinic

Warangal, Telangana, India

Site Status

Countries

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India

Other Identifiers

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FRT-PN-18

Identifier Type: -

Identifier Source: org_study_id

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